Understanding the factors influencing the adoption of biosimilars; an innovation theory perspective

Understanding the factors influencing the adoption of biosimilars; an innovation theory perspective | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Understanding the factors influencing the adoption of biosimilars; an innovation theory perspective Dunia Alqadi, Aziz Madi This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6899804/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract This research explores the factors influencing the adoption of biosimilars by Jordanian pharmaceutical companies, employing the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory. Using an exploratory qualitative design, semi-structured interviews were conducted with five key stakeholders, including senior executives from leading pharmaceutical firms and the Jordan Food and Drug Administration (JFDA). The findings confirm a consensus on the relative advantages of biosimilars—such as improved affordability, access, and competitiveness. However, substantial barriers to adoption were also found. From the pharmaceutical companies’ perspective, key challenges include high manufacturing costs, investment risks, and a lack of internal expertise, as current involvement is limited to secondary packaging. From the regulatory authority’s viewpoint, barriers include insufficient local infrastructure, limited biosimilar-specific testing labs, and skepticism from healthcare professionals and patients. The study provides theoretical contributions by extending the TOE and DOI frameworks to the biosimilar context in a developing market, highlighting unique organizational and environmental variables. Practically, this research contributes to decision makers in pharmaceutical companies, regulatory institutions, and suggests practical steps to enhance the adoption in biosimilars, contributing to long-term healthcare cost containment and innovation. Health Economics & Outcomes Research Clinical Pharmacology Health Policy Food Science & Technology Adoption barriers Biosimilars Diffusion of Innovation (DOI) Healthcare innovation Jordan Pharmaceutical industry Regulatory frameworks Technology-Organization-Environment (TOE) Figures Figure 1 1. Introduction According to estimates, the worldwide biosimilar industry is expected to develop at a compound annual growth rate (CAGR) of 30.9%, reaching USD 60 billion by 2025 (Priyarega & Natarajan, 2022 a). With cumulative sales are predicted to reach USD 129 billion over the following five years. (IQVIA, 2023 ). Currently, $ 38 billion is spent on molecules that are up against biosimilar competition, and an additional $ 96 billion is anticipated to be spent on biologics that will join the biosimilar market. The same research states that IQVIA predicts that by 2027, biosimilar spending in the United States will have increased significantly, establishing biosimilars as affordable options for the treatment of complicated and chronic illnesses (IQVIA, 2023 ). Among the key factors that are driving biosimilar growth worldwide is the rising chronic disease prevalence, the demand of an expanding patient base, significant financial savings for healthcare systems, enhanceed patient accessibility (as biosimilars are usually 20%-30%% less expensive than their reference biologics), favorable regulatory changes, and patent expirations of major biologics that opens the market for biosimilar competitions ((IQVIA, 2023 ; Priyarega & Natarajan, 2022 ; Gherghescu & Delgado-Charro, 2021); Kurki et al., 2021 ). However, despite the excellent clinical efficacy of these treatments, a number of obstacles have prevented their widespread use, including regulatory obstacles, patient misunderstandings, and healthcare professional distrust. (Afshari-Mofrad & Salim, 2020 ; Ghaleb et al., 2021 ). Current research on the adoption of biosimilars frequently concentrates on discrete elements. For example, a systematic review by Leonard et al. ( 2019 ) showed that a major obstacle to the prescription of biosimilars is the lack of information and concerns regarding safety and efficacy among healthcare practitioners (Leonard et al., 2019 ). Moorkens et al. (2020) examined European biosimilar adoption policies, focusing on how pricing, market incentives, and bidding procedures affect adoption. These studies, however, only look at particular aspects of the adoption process; they don't take into account the organizational, technical, and environmental elements that influence how biosimilars are implemented in various markets (Moorkens et al., 2017 ). Furthermore, no comprehensive research has systematically examined the variables influencing the adoption of biosimilars in developing countries, where the health care systems and patients can represent a perfect alignment for a cost efficient solution. There is a significant knowledge gap in how pharmaceutical firms, healthcare providers, and policymakers manage the introduction of biosimilars because the majority of existing papers concentrate on biosimilar rules rather than adoption drivers (Al-ali Malkawi et al., 2018 ; Haddadin, 2011 ) In order to address this gap, this research uses the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to systematically analyze biosimilar adoption in Jordan. The TOE framework provides an in-depth evaluation of the technological, organizational, and environmental factors that affect the adoption of biosimilars. At the same time, DOI theory makes it easier to analyze how biosimilars diffuse throughout stakeholders, emphasizing important factors as relative advantage, compatibility, trialability, complexity, and observability. By combining these frameworks, the research seeks to give policymakers, healthcare professionals, and industry stakeholders a comprehensive knowledge of biosimilar adoption and useful advice on how to increase biosimilar market penetration in Jordan. This study aims to investigate and evaluate the key factors of biosimilar adoption in Jordanian pharmaceutical companies. Using the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory, the study attempts to offer a systematic understanding of the technological, organizational, and environmental factors, as well as the innovation-specific traits that influence the adoption of biosimilars. From the viewpoints of regulatory bodies and stakeholders in the pharmaceutical sector, this study aims to identify adoption facilitators and barriers. In doing so, this study has the following research question: RQ1: What factors could facilitate a successful adoption of biosimilar manufacturing in Jordanian pharmaceutical companies? By answering the research question, this study introduce several theoretical and practical contributions. This research applies the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to the adoption of biosimilars, although these frameworks have been extensively employed in research on technology adoption, little is known about how they may be applied in the biosimilar industry, especially in a developing country like Jordan. Additionally, this study fills a gap in the literature on the adoption of biosimilars in developing markets, since the majority of previous research has been on developed economies. This expansion increases these theories' generalizability and increases their applicability in many regulatory and healthcare sectors. As for the practical contributions of this research, it offers evidence-based suggestions for healthcare institutions to accelarete the adoption of biosimilars in developing countries, in addition, regulatory authorities can accelerate approval processes and ease the introduction of biosimilars into the market. Pharmaceutical firms can understand the important technological, organizational and environmental factors that may increase their competitiveness and enhance their adoption strategy. And finally, medical professionals may learn more about the elements that affect the acceptability of biosimilars, and the factors that will lead to the adoption, which will eventually improve patient access to reasonably priced treatments. The structure of this study unfolds as follows: it begins with a review of relevant literature, followed by a detailed explanation of the research methodology. The subsequent section presents the findings from the interviews, from which key themes are derived. These findings are then discussed in depth in the discussion section. The study concludes by outlining its theoretical and practical implications, acknowledging its limitations, and offering recommendations for future research. 2. Literature Review 2.1 Theoretical Framework To understand the factors influencing biosimilar adoption, this research applies two theoretical models: the Technology-Organization-Environment (TOE) Framework and the Diffusion of Innovation (DOI) Theory. Each model offers a unique lens through which to analyze the variables that shape adoption, covering both the technological, organizational, and environmental elements, as well as the social dynamics within healthcare settings that influence the acceptance of new technologies such as biosimilars (Al Teneiji et al., 2024 ). 2.1.1 Technology-Organization-Environment (TOE) Framework The Technology-Organization-Environment (TOE) framework, developed by Tornatzky and Fleischer in 1990 (Cruz-Jesus et al., 2019 , Tronatzky and Fleishcer (1990), classifies the factors of an enterprise that influence the adoption of innovation into three factors: Technological, Organizational, and Environmental. This model has been widely applied in healthcare to understand how firms adopt innovation by highlighting both internal and external factors (Al Teneiji et al., 2024 ; Mujalli et al., 2024 ; Qatawneh, 2024 ; Yang et al., 2024 ). Technological, organizational, and environmental factors can include several factors according to the theory. Technological factors refer to the firm’s relevant internal and external technologies, in addition to those that are accessible for adoption. Organizational factors refer to the descriptive characteristics of the firm (such as organizational structure, firm size, managerial structure, and degree of centralization), its resources (human and slack resources), and the formal and informal channels of employee communication. Environmental factors include the market elements, competitors, and the regulatory environment. (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., 2019 ), hereafter is the explanation of these factors and how they can be related to biosimilars. 2.1.1.1. Technological Factors Within the TOE (Technology-Organization-Environment) framework, technological factors refer to all the internal and external relevant technology of an organization, both the present internal technology accessible inside the organization, and other available external technologies, i.e., those that are available outside but not adopted yet by the organization (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., 2019 ). In this context, however, one might usefully think of technology in material (e.g., equipment) and/or immaterial (e.g., data and methods in use). The technological factors separated to highlight focus on how attributes of the technology itself drive adoption decision. These factors provide insight into the potential benefits and challenges organizations might experience when adopting new innovations (Tornatzky & Fleischer (1990), (Cruz-Jesus et al., 2019 )). Within the healthcare domain, several studies emphasized that technological factors play a crucial role in impacting innovation adoption. Cruz-Jesus et al. ( 2019 ) highlighted the importance of technological characteristics, including compatibility, complexity, and relative advantages, in determining adoption levels for CRM technologies stages which facilitated their uptake as innovations. Similarly, Ghaleb et al. ( 2021 ) investigated healthcare employees' readiness to adopt big data technologies based on the TOE framework with a particular focus on alignment of technological advance with organizational readiness in facilitating innovation. Furthermore, in the study on e-participation adoption by Pašalić and Ćukušić (2024) have noted that especially facilitate technological factors like system reliability or ease of use makes a large contribution to the successful organizational adoption of innovations. Together, these findings elaborate that technological factors play an essential role in innovation adoption, both within and outside the healthcare sector. These factors are operationalized in this research as the availability of manufacturing technology, whether internally available or externally accessible, by the Jordanian pharmaceutical companies. Therefore, this research proposes the following: P1: The technological factors, if available, play a key role in Jordanian pharmaceutical companies to adopt biosimilars manufacturing. 2.1.1.2. Organizational Factors The TOE framework's organizational factors refer to the descriptive characteristics of the firm (such as organizational structure, firm size, managerial structure, and degree of centralization), its resources (human and slack resources), and the formal and informal channels of employee communication (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., 2019 ). Another important factor that might help or hinder the adoption of an invention is the support of top management. Multiple opinions exist about the function of slack resources inside companies. Even though businesses want to have slack, this does not always help the adoption process. There is currently no clear correlation between size and adoption rate, nor is the function of scale in embracing innovations fully recognized (Amini & Bakri, 2015 ; Cruz-Jesus et al., 2019 ) The Firm’s Characteristics The firm’s characteristics in this context refer to organizational structure, firm size, managerial structure, and degree of centralization ,(Amini & Bakri, 2015 p.124) These characteristics are identified as essential factors in the innovation adoption process (Qatawneh, 2024 ; Salah & Ayyash, 2024 ; Zhong & Moon, 2023 ). The organizational structure can facilitate or obstruct the adoption of new technologies, particularly in specialized sectors. Large companies often have superior resources and well-defined management frameworks, enabling more effective decision-making and resource distribution (Amini & Bakri, 2015 ; Cruz-Jesus et al., 2019 ). Nevertheless, certain organizations must implement a level of centralization, as excessive decision-making by subsidiaries might hinder the adoption of innovations (Qatawneh, 2024 ). The healthcare sector's adoption of new technologies often depends on interdepartmental collaboration, highlighting the necessity of adaptable organizational structures (DiMasi et al., 2016 ; Ghaleb et al., 2021 ). This research operationalized the firm's distinctive elements, including organizational structure, firm size, management structure, and degree of centralization. The Firm’s Resources The firm’s resources in this context refer to human and slack resources (Amini & Bakri, 2015 , p. 124). Human resources, containing skilled employees and expertise, are essential for the management and execution of new initiatives in biotechnology. The availability of skilled professionals in the healthcare industry substantially influences the effectiveness of biopharmaceutical efforts (Afshari-Mofrad & Salim, 2020 ). Slack resources, characterized as the excess resources available beyond operational requirements, provide firms with the opportunity to invest in innovation. Slack resources enable firms to allocate funds toward research, development, and regulatory compliance, which are critical components of the adoption process for new medicines. These resources help overcome financial barriers and facilitate the integration of innovative treatments into clinical practice (Reichert, 2003 ; Medlinskiene et al., 2021 ). This research defines the firm's resources as human and slack resources. Human resources include the skills, expertise, and training of workers involved in production. Slack resources indicate surplus financial, technical, or operational assets that offer flexibility for investment in innovation, research, and adherence to regulatory requirements (Qatawneh, 2024 ). The Firm’s Channels of Communication The firm’s communication channels in this context refer to the formal and informal channels of employee communication (Cruz-Jesus et al., 2019 ). Both formal and informal communication channels are critical to ensure a culture of innovation and receptiveness towards technology adoption. Formal methods, including scheduled meetings, reports, and hierarchical communications, facilitate clear guidance and responsibility in the process of innovation. Informal methods, such as individual conversations and cross-departmental collaborations, facilitate the transfer of unspoken knowledge and foster creative problem-solving, which are crucial in the dynamic manufacturing sector (Salah & Ayyash, 2024 ; Zhong & Moon, 2023 ). Research in the healthcare industry suggests that teams need to communicate effectively to alleviate concerns and share best practices when carrying out active innovations (Ghaleb et al., 2021 ; Greenhalgh et al., 2004 ; Raymond K. Cross et al., 2022 ). The firm’s communication are operationalized in this research as both formal and informal communication. Formal channels refer to structured meetings, reports, and hierarchical communications. Informal channels refer to peer-to-peer interactions and cross-departmental collaborations. Top Management Support The role of top management support is very critical in acting as an enabler to innovation adoption. Innovative leaders create a culture of innovation within their organizations, providing capital and resources while minimizing the resistance to change. In the healthcare sector, managerial assistance is crucial for overcoming obstacles to the implementation of breakthrough therapies and fostering collaboration across teams. The commitment of senior management is essential for cultivating an organizational culture that emphasizes continuous improvement and aligns the implementation of innovation with overarching objectives, such as cost reduction and improved patient outcomes (Medlinskiene et al., 2021 ; Saeed et al., 2023 ). The top management support is operationalized in this research as the active role of senior leaders in promoting Biosimilar adoption. Based on that, this research proposed the following: P2: The current organizational factors in Jordanian pharmaceutical companies support the adoption of manufacturing biosimilars. 2.1.1.3 Environmental Factors: Environmental factors, including regulatory requirements, competitive pressures, and societal attitudes, profoundly impact the biosimilar adoption scenario. Beneficial laws and streamlined approval procedures diminish entry barriers, promoting the incorporation of biosimilars into clinical practice for healthcare organizations. Regulatory frameworks governing patent expirations and fostering competition—especially in countries with evolving legislation like India—significantly bolster the growth of the biosimilar business by enabling the swift launch of affordable alternatives (Afshari-Mofrad & Salim, 2020 ; Priyarega & Natarajan, 2022 a) The rivalry within the pharmaceutical sector, intensified by the emergence of several biosimilar alternatives, diminishes prices, hence improving accessibility for healthcare providers and patients. This market-oriented cost decrease enhances the appeal of biosimilars, particularly in economically sensitive healthcare settings. Moreover, societal attitudes, encompassing the viewpoints of patients and healthcare workers, are crucial for acceptance. Educational programs addressing psychological hurdles, such as the nocebo effect, are essential for enhancing acceptance, since they reduce uncertainty about the efficacy and safety of biosimilars. The TOE framework proposes that external environmental factors are crucial determinants that can either facilitate or obstruct the adoption of biosimilars in healthcare contexts, based on existing regulatory, market, and societal dynamics (Ghaleb et al., 2021 ). Regulatory Requirements Regulatory requirements are critical factors in the adoption of biosimilars, as it encompasses policies, guidelines, and approval processes established by government bodies to regulate biosimilar entry and usage. Establishing regulatory standards, streamlining approval procedures, and providing instructions on interchangeability can facilitate the smooth incorporation of biosimilars into healthcare systems. Countries with advantageous rules, such as those inside the European Union, frequently see heightened biosimilar adoption owing to well delineated criteria and expedited licensing procedures (Afshari-Mofrad & Salim, 2020 ; Ghaleb et al., 2021 ). However, countries with rigorous or undefined regulatory frameworks may have decreased adoption rates due to increased market entry barriers (Regulatory Complexities and Challenges of Biosimilars, 2019). This research put into practice the regulatory requirements concerning the perception of policies, guidelines, and approval processes set by governmental entities, and whether these are perceived as supportive or restrictive to the adoption of biosimilars. Competitive Pressures Competitive pressure reflects the influence of market dynamics and competition on the uptake of biosimilars. Following the expiry of patents for reference biologics, biosimilars enter the market, enhancing competition that encourages price reductions and cost-saving measures for healthcare providers. In areas with several biosimilar options, increased competition often lowers prices, improving the accessibility and appeal of biosimilars for healthcare systems and patients (IQVIA, 2023 ; Medlinskiene et al., 2021 ). This rivalry prompts healthcare professionals to regard biosimilars as a viable option to pricier biologics, particularly in cost-sensitive healthcare environments. The competitive pressures in this reasearch are be operationalized as the availability of multiple biosimilar alternatives available to pharmaceutical companies in Jordan. Societal Attitudes Societal Attitudes encompass the perceptions and acceptance levels of biosimilars among patients, healthcare providers, and the general public. Acceptance is sometimes influenced by variables such as the nocebo effect (where adverse expectations diminish perceived treatment efficacy), disinformation, or inadequate understanding of the safety and effectiveness of biosimilars (Medlinskiene et al., 2021 ; Raymond K. Cross et al., 2022 ). Favorable public perceptions, cultivated via education and awareness initiatives, can augment trust in biosimilars, hence promoting their integration into treatment protocols. Confronting these views is crucial, since opposition or mistrust from patients and healthcare professionals may obstruct the incorporation of biosimilars in healthcare environments (Gerard Quinn, 2024 ). This research operationalizes social views as the perceptions and acceptance levels of biosimilars among patients and healthcare providers. Based on that, this research proposes the following: P3: The environmental factors in Jordanian pharmaceutical market are supportive to adoption of biosimilars manufacturing. 2.1.2 Diffusion of Innovation (DOI) Theory Diffusion of Innovation (DOI) Theory offers a comprehensive framework for understanding how new ideas, technologies, or practices spread through social systems. Established by Everett Rogers in 1962, the Diffusion of Innovations (DOI) theory defines key factors influencing the rate of adoption and integration of innovations within companies and among individuals (Everett M.Rogers, 2003 ). Within the field of healthcare, DOI theory clarifies the factors that affect the acceptability and adoption of biosimilars, an innovative category of biologics intended to deliver comparable effectiveness and safety profiles to reference biologics while being more cost-effective (Ghaleb et al., 2021 ; IQVIA, 2023 ). DOI theory’s factors— Relative Advantage, Compatibility, Complexity, Trialability, and Observability — are especially important for understanding the acceptance of healthcare providers and organizations to biosimilars. Analyzing each factor provides insights into the viewpoints, attitudes, and challenges influencing the adoption of biosimilars in healthcare environments (Gledson, 2022 ; Qutaishat et al., 2023 ). Relative Advantage (RA) Relative Advantage (RA), an essential factor of technology adoption, denotes the perceived benefits of new technologies in comparison to existing alternatives(Al Teneiji et al., 2024 ; Cupido & Jokonya, 2024 ; Ninčević Pašalić & Ćukušić, 2024 ; Qatawneh, 2024 ; Rehman et al., 2024 ; Zhu et al., 2006 ). Relative advantage is defined as “the degree to which an innovation is perceived as being better than the idea it supersedes”(Everett M. Rogers, 2003 , p. 229). Relative Advantage (RA) is acknowledged in literature as a promoter for technological adoption, frequently associated with improved performance, operational efficiency, and cost-effectiveness. In supply chain contexts, blockchain technology's ability to enhance transparency is a notable advantage that fosters trust and visibility across supply networks (Francisco & Swanson, 2018 ; Kamble et al., 2019 ). Biosimilars in healthcare have considerable relevance by offering a cost-effective substitute for expensive biologics while preserving therapeutic equivalence. This affordability improves patient accessibility, especially in cost-sensitive markets and price-sensitive healthcare systems addressing chronic conditions like rheumatoid arthritis and cancer. Recent studies indicate that biosimilars can decrease healthcare costs by around 20–30%, a significant advantage for healthcare providers working under limited resources (Afshari-Mofrad & Salim, 2020 ; Gerard Quinn, 2024 ; IQVIA, 2023 ). The presence of biosimilars in the market enhances competitiveness, leading to decreased costs for original biologics and further solidifying the perceived advantages of employing biosimilars (Medlinskiene et al., 2021 ; Priyarega & Natarajan, 2022 a; Raymond K. Cross et al., 2022 ). Biosimilars enhance healthcare equity by broadening access to biologic medicines in areas where the exorbitant cost of reference biologics restricts availability. Research on emerging markets highlights the revolutionary capacity of biosimilars in enhancing the accessibility of innovative medicines to a wider patient population (Ghaleb et al., 2021 ; Shaina Shah & Pranav Patel, 2022). Consequently, regulatory approval for biosimilars aligns with healthcare organizations' objectives to enhance treatment cost and accessibility, particularly in contexts where biologics have traditionally been less accessible. Therefore, companies’ conscious of these benefits should be compelled to adopt biosimilars. This research describes relative advantages as the benefits derived from developing biosimilars, proven by improved performance, operational efficiency, and/or cost-effectiveness. Based on that, this research proposes the following: P4: Adopting biosimilars production line provides notable relative advantage to Jordanian manufacturers that is easy to quantify. Complexity Complexity, a key factor of the DOI theory, denotes the perceived challenges linked to understanding, executing, and integrating new technologies (Al Teneiji et al., 2024 ; Nam et al., 2021 ; Prasad Agrawal, 2024 ; Rehman et al., 2024 ). Complexity is “ the degree to which an innovation is perceived as relatively difficult to understand and use ” (Everett M.Rogers, 2003 , p. 257). The literature on technology adoption has extensively examined complexity, indicating that advanced technological systems often require significant technical expertise (Afshari-Mofrad & Salim, 2020 ; Hnoosh & Courmier, 2018 ), comprehensive education for healthcare professionals (Al Teneiji et al., 2024 ; Shaina Shah & Pranav Patel, 2022), and considerable organizational resources for successful integration (Cruz-Jesus et al., 2019 ; Prasad Agrawal, 2024 ) In several businesses, particularly those necessitating high precision and regulatory adherence, complexity often constitutes a substantial obstacle to adoption(Cruz-Jesus et al., 2019 ; Everett M.Rogers, 2003 ). Research on technology adoption indicate that complex technologies necessitate comprehensive training, elevated technical proficiency, and increased organizational resources, potentially resulting in lowered adoption rates (Zhu et al., 2006 ). The complexity of integrating biosimilars into healthcare is particularly evident due to their advanced production methods and strict regulations. Biosimilars need rigorous quality controls to ensure safety and efficacy, hence delaying their production and market entry. These constraints can lead to increased production expenses, hindering market penetration (Afshari-Mofrad & Salim, 2020 ). Moreover, studies by Medlinskiene et al. ( 2021 ) and Raymond K. Cross et al. ( 2022 ) underscore the significance of accurate molecular replication and thorough clinical testing, both of which add further regulatory and industrial complexity to the development of biosimilars. Regulatory regulations required comprehensive comparability studies and post-marketing surveillance for biosimilars to ensure therapeutic equivalence with originator biologics, therefore increasing their complexity. Compliance regulations provide significant challenges for firms in underdeveloped nations, since resource constraints impede market access (Ghaleb et al., 2021 ; Priyarega & Natarajan, 2022 b). The successful integration of biosimilars into healthcare necessitates comprehensive training for physicians and education for patients, especially in addressing misconceptions like the nocebo effect, which may influence patient acceptability (Gerard Quinn, 2024 ; IQVIA, 2023 ). Biosimilars are inherently more complex than other pharmaceutical treatments due to the intricate technologies involved, requiring lengthy testing and thorough comparison studies as demanded by regulatory agencies. Therefore, companies may exhibit resistance in adopting this technology. The complexity in this research is operationalized as the perceived difficulty associated with understanding, implementing, and integrating biosimilars. Accordingly, this research has the following proposition: P5: The perceived complexity in the production and quality control of biosimilars acts as a barrier to adoption in less technologically advanced organizations. Compatibility Compatibility in technology adoption indicates the extent to which a new technology fits with an organization’s existing values, practices, systems, and infrastructure. Compatibility is “ the degree to which an innovation is perceived as consistent with the existing values, past experience, and needs of potential adopters ” (Everett M.Rogers, 2003 , p. 240). High compatibility frequently facilitates adoption by reducing the need for substantial modifications to existing processes (Tornatzky & Fleischer, (1990), (Cruz-Jesus et al., 2019 ); (Everett M.Rogers, 2003 )). Studies across several industries demonstrate that technologies aligned with current organizational norms and procedures see greater adoption rates (Hasan Emon & Hoque Nahid, 2023; Zhong & Moon, 2023 ). The adoption of Industry 4.0 technologies in the industrial sector has been significantly influenced by their compatibility with existing processes and organizational culture (Zhong & Moon, 2023 ). Studies on the adoption of healthcare technology demonstrate that congruence with established procedures and organizational culture is essential for successful integration (Al Teneiji et al., 2024 ; Ghaleb et al., 2021 ; Medlinskiene et al., 2021 ) In the context of biosimilars, compatibility denotes adherence to prevailing healthcare practices, clinical standards, and the anticipations of healthcare practitioners. Biosimilars that can be seamlessly integrated into treatment regimens without necessitating substantial modifications are more likely to be embraced by healthcare professionals and patients (Afshari-Mofrad & Salim, 2020 ; IQVIA, 2023 ). Compatibility necessitates educational activities; healthcare professionals must be informed and adept in biosimilar medicines to effectively integrate them into medical environments (Gerard Quinn, 2024 ; Medlinskiene et al., 2021 ). This research defines compatibility to the extent to which biosimilars fit with an organization's established values, practices, systems, and infrastructure. Therefore, for this purpose, the following proposition is developed for this research: P6: The compatibility of manufacturing biosimilars with the existing values, practices, systems, and infrastructure in Jordanian pharmaceuticals represents a challenge to the adoption process. Trialability Trialability, a critical factor influencing technology adoption, which measures how easily an invention may be tried out or evaluated before being fully implemented (Al Teneiji et al., 2024 ; Amini & Bakri, 2015 ; Salah & Ayyash, 2024 ). Everett M. Rogers ( 2003 ) formally defined trialability as “ the degree to which an innovation may be experimented with on a limited basis ”. This factor is recognized in the literature as an adoption facilitator, since it allows companies to assess the risks, benefits, and operational consequences of a new technology prior to its complete integration (Everett M.Rogers, 2003 , p. 258). Technologies characterized by high trialability are more open to acceptance, since they facilitate education and adaptation, thereby reducing the uncertainties linked to adoption (Afshari-Mofrad & Salim, 2020 ; Ghaleb et al., 2021 ). In healthcare, trialability is essential due to the substantial risks associated with patient safety and treatment efficacy. Before the extensive implementation of novel treatments or technology, healthcare providers can evaluate outcomes and tackle obstacles via smaller-scale studies. The deployment of electronic health records (EHRs) generally involved incremental introductions or pilot programs to aid staff acclimatization and methodically address technological issues (Medlinskiene et al., 2021 ; Shaina Shah & Pranav Patel, 2022). Innovative diagnostic procedures and medical devices are frequently assessed in controlled environments or specific patient cohorts to gather data on their reliability, usability, and efficacy before broad deployment (Al Teneiji et al., 2024 ; Saeed et al., 2023 ). In the field of biosimilars, trialability is crucial for mitigating skepticism among healthcare professionals and patients. Biosimilars, unlike original biologics, can be evaluated in transitional patient populations, providing an opportunity to demonstrate therapeutic equivalence and safety. Research indicates that healthcare professionals are more likely to support the broader implementation of biosimilars in treatment protocols when provided with clinical evidence about their safety and efficacy (IQVIA, 2023 ; Raymond K. Cross et al., 2022 ). This stepwise model for biosimilar introduction allows stakeholders to recognize issues related to immunogenicity, side effects, and patient acceptability. This project introduces tribality by enabling healthcare practitioners and patients to trial or evaluate biosimilars before full deployment. Accordingly, this research has the following proposition: P7: The ease and affordability of trialability of biosimilars in Jordan encourages Jordanian pharmaceuticals companies to adopt such new manufacturing line. Observability Observability, another critical factor influencing technology adoption, refers to the degree to which the results and benefits of an innovation are visible to others (Amini & Bakri, 2015 ; Gledson, 2022 ; Greenhalg et al., 2004; Salah & Ayyash, 2024 ). Everett M. Rogers ( 2003 ) defined observability as “ the degree to which the results of an innovation are visible to others ”. Innovations with readily visible outcomes typically attain higher adoption rates, since their benefits can be clearly shown and communicated to potential adopters (Everett M.Rogers, 2003 , p.258). Literature constantly emphasizes observability as a critical aspect in technology dissemination, positing that the visibility of concrete outcomes and success narratives reduces ambiguity and bolsters adoption confidence (Al Teneiji et al., 2024 ; Ghaleb et al., 2021 ). In healthcare, observability profoundly influences the acceptance and dissemination of novel concepts within the sector. Exhibiting the effectiveness of novel technology or therapy, such as improved patient outcomes or cost reductions, motivates stakeholders to embrace the innovation. The adoption of telemedicine surged significantly as a result of the COVID-19 pandemic's clear enhancements in healthcare delivery. Research indicates that the demonstration of concrete benefits, including decreased hospitalizations and enhanced patient satisfaction, promoted the extensive use of telemedicine services (Medlinskiene et al., 2021 ; Valencia-Arias et al., 2024 ). In the realm of biosimilars, observability is essential for alleviating mistrust among healthcare professionals and patients. The demonstrable impact of biosimilars in reducing treatment costs, improving access to biologics, and maintaining therapeutic equivalence with original medications is a significant factor facilitating their acceptance.Healthcare systems that have adopted biosimilars frequently report quantifiable cost reductions of 20–30% (2023 U.S. Generic and Biosimilar Savings Report: Biosimilars Deliver on Their Promise, 2023; “Biosimilars of Infliximab,” 2020; Alawneh et al., 2022 ; Fda et al., 2015; IQVIA, 2023 ; Kurki et al., 2021 ; Priyarega & Natarajan, 2022 a; Scott Morton et al., 2018 ; Victoria Johnson, 2024 ). The introduction of biosimilars in the market has demonstrated a reduction in the costs of original biologics, resulting in improved affordability within healthcare systems and highlighting the competitive pricing benefits of biosimilars (2023 U.S. Generic and Biosimilar Savings Report: Biosimilars Deliver on Their Promise, 2023; Gasteiger & Petrie, 2022 ; Hnoosh & Courmier, 2018 ; IQVIA, 2023 ; LUPIN, 2023 ; Victoria Johnson, 2024 ). This research operationalizes observability to the extent to which the outcomes and advantages of biosimilars are visible to key stakeholders, including healthcare providers, patients, and pharmaceutical companies. Based on that, this research proposes the following: P8: The observability of manufacturing and using biosimilars in Jordan’s limited and well-regulated market facilitates the organizational decision regarding biosimilar adoption. 2.2 Application of TOE and DOI to Manufacturing Biosimilars The TOE and DOI frameworks offer complementary perspectives on biosimilar adoption. The TOE framework emphasizes the organizational and environmental contexts, while DOI focuses on the perceived attributes of innovation by internal staff and departments in greater detail. Applying both frameworks to biosimilars provides a holistic view of adoption barriers and drivers, addressing the unique challenges posed by biosimilar integration in healthcare, particularly in Jordan. Prior Applications of TOE and DOI in Healthcare The Diffusion of Innovations (DOI) theory and the Technology-Organization-Environment (TOE) framework, either individually or in combination, have been widely used to study the adoption of healthcare technology, providing thorough insights into how innovations are assessed and incorporated (Al Teneiji et al., 2024 ; Amini & Javid, n.d.; Bakshi et al., 2022 ; Cruz-Jesus et al., 2019 ; Ghaleb et al., 2021 ; Macabasag et al., 2023 ; Raymond K. Cross et al., 2022 ; Rouidi et al., 2022 ; Valencia-Arias et al., 2024 ). The introduction of biosimilars in the market has demonstrated a reduction in the costs of original biologics, resulting in improved affordability within healthcare systems and highlighting the competitive pricing benefits of biosimilars. For example, CRM technology adoption study used the TOE framework, emphasizing how organizational external factors influence adoption procedures (Cruz-Jesus et al., 2019 ). Furthermore, Implementation of Human-Computer Interaction (HCI) system in healthcare highlighted the importance of the TOE framework to enhance service delivery and usability (Mehta & Chaudhary, 2022 ). The DOI theory enhances the TOE framework by examining the dissemination of innovations in organizations, emphasizing aspects such as relative benefit, compatibility, complexity, trialability, and observability. Employing DOI, Bakshi et al. (2021) examined the influence of robots’ integration in healthcare on stakeholder acceptability and decision-making (Bakshi et al., 2022 ). Rouidi et al. ( 2022 ) utilized the Diffusion of Innovations (DOI) theory in conjunction with other models to investigate health professionals' acceptance of telemedicine, revealing that adoption is influenced by communication routes and perceived benefits (Rouidi et al., 2022 ). Macabasag et al. (2022) emphasized the significance of DOI in comprehending the obstacles and enablers in the implementation of electronic medical records by illustrating the relationship between technical design and user experience (Macabasag et al., 2023 ). The TOE framework and DOI theory, when integrated, provide efficient methods for examining the adoption of healthcare technologies by considering macro-level factors (including technological, organizational, and environmental factors) and micro-level factors (such as relative advantage, complexity, compatibility, trialability and observability.. The TOE (Technology-Organization-Environment) framework is particularly useful in this research because Jordan is a developing country and not a technology producer. Therefore, it is essential to assess whether the technology required for biosimilar manufacturing is available or accessible. Additionally, despite having a well-regulated pharmaceutical industry, Jordan's pharmaceutical manufacturing facilities are relatively new when compared to those in developed countries. The TOE framework enables an analysis of the technological and regulatory infrastructure that might either facilitate or hinder the adoption of biosimilar. While the Diffusion of Innovations (DOI) framework fits well with the research focus because one of the key questions is about the strategies and policies that can ensure the successful adoption of biosimilars in Jordan. To answer this, it is important to look at how prepared pharmaceutical companies are internally and what drives their readiness to adopt such innovations. By applying the DOI framework, we can gain insights into what has worked and what can be improved, offering recommendations that can be applied more broadly. The adoption of biosimilars is influenced by a combination of technological advancements, organizational readiness, and environmental factors. By examining these through the TOE framework, this research provides a comprehensive understanding of the key drivers behind biosimilar market growth, particularly in developing countries where cost considerations and regulatory support are critical. Insert Figure 1 about here. 3. Methodology 3.1 Research design This research uses a qualitative research methodology to investigate the factors influencing the adoption of biosimilars in Jordanian pharmaceutical companies. Qualitative research is particularly suitable when the objective is to comprehend underlying motivations and contextual factors (Mishra & Alok, 2017 ). The research employs exploratory design and uses semi-structured interviews to gather in-depth information from regulatory authorities and business executives who are well-experienced with biosimilars (directly or not directly) during the last 5 years (see appendix A). Mishra and Alok ( 2017 ) assert that exploratory research is suitable for comprehending issues that are not yet distinctly characterized or where current explanations are inadequate. Semi-structured interviews provide flexibility, allowing the researcher to delve deeper into emergent themes while preserving consistency across interviews. A total of five interviews were conducted, focusing on those with high-level experience and decision-making authorities in the adoption of biosimilars. The interview questions were sent to respondents before to allow them to provide thoughtful and evidence-based responses. This design enables the exploration of contextual factors that are critical for understanding biosimilar adoption in the Jordanian pharmaceutical companies. 3.2 Sample design The target population includes all the stakeholders that might have a say in biosimilar adoption. In this case, these are pharmaceutical companies and regulatory authorities. From this population, the researcher has selected a sample. The research utilized non-probability purposive sampling method, specifically expert sampling, which is suitable for qualitative research that seeks in-depth insights from individuals with specialized knowledge. This approach ensures the inclusion of key decision-makers and stakeholders with direct experience in biosimilar-related strategies and policies (Mishra & Alok, 2017 ). A sample of five high-level managers from Jordan’s pharmaceutical and regulatory sectors, the selection of these individuals was based on their direct participation in biosimilar adoption decision-making, which guaranteed the capture of rich, contextually relevant data. These participants include Tender manager, Vice President, Associate Director, and Marketing Director from three major pharmaceutical companies manufacturing Biosimilars and Manager Director of the Jordan Food and Drug Administration (JFDA). Although this sample is not representative of all stakeholders and cannot be generalized to this sample is suitable for exploratory research even if it is not representative of all stakeholders and cannot be generalized for the whole industry. The individuals selected are excellent resources to understand the main barriers, drivers, and decision-making procedures in this setting since they have extensive knowledge and direct experience with biosimilar adoption in Jordan. 3.2 Data Collection Data was collected through semi-structured interviews which lasted approximately 60 minutes each. An interview guide was developed based on the research’s objectives, ensuring consistency across interviews. With the participants' permission, each interview was audio recorded, and the verbatim transcriptions were then analyzed. The interviews were conducted mainly in Arabic, keeping the questioning and the medical terms in English. First the transcriptions were done in Arabic and then translated into English for analysis. A professional translator was recruited for this purpose to ensure correctness of translation. Two university professors examined the interview questions to make sure they were understandable, pertinent, and in line with the research's goals. Additionally, Member verification, in which participants examined their transcripts to verify the correctness of their answers, was used to guarantee the findings' reliability (Mishra & Alok, 2017 ). 3.3 Data Analysis Data analysis follows a thematic approach, allowing for systematic identification of patterns and themes across the interview data. Each interview transcript analyzed to extract key themes related to biosimilar adoption, drawing directly from participant responses to ensure authenticity. Thematic analysis is a popular method for examining qualitative data that involves finding, studying, and summarizing recurrent themes or patterns in the dataset. The ability to arrange and analyze vast amounts of textual material while keeping a close relationship to the original context makes it especially useful in systematic reviews and primary qualitative research (Thomas & Harden, 2008 ). This process involves coding and categorizing data, identifying overarching themes that reflect the research's research questions. Direct participant quotes is integrated into the analysis to support thematic findings, offering depth and grounding to the conclusions. This approach is particularly effective for exploratory studies, as it provides a structured yet flexible means of capturing the nuanced perspectives of participants, ultimately yielding insights that are both comprehensive and contextually relevant (Thomas & Harden, 2008 ). 4. Research Findings This section presents a thematic analysis of in-depth interviews conducted with key stakeholders in the Jordanian pharmaceutical sector. 4.1 Technology-Organization-Environment (TOE) Framework Key Findings A. Technological context Theme A.1 Limited Internal Technological Capabilities The findings indicate that Jordan lacks internal technology for producing biosimilars. In addition, Jordanian pharmaceutical companies do not have the know how to develop and produce biosimilars. Only a few companies appear capable of investing in the required technologies. Therefore, there was an theme of answers indicating that outsourcing manufacturing might be a sound resolution for Jordanian pharmaceutical companies. The Associate Director underlined this barrier by saying: " the evaluation was "very low" as most companies import the biosimilar and only fill it. From my experience, there are contacts for a partial contact process in some countries, so it is difficult to find a way to manufacture it ". Theme A.2 Challenges in Technology Transfer and Access to External Technologies While partnerships are theoretically possible, the findings emphasize that access to technology is not easy. The interviewees had a perception that the cost to acquire the technology to produce biosimilars in Jordan is beyond the capabilities of Jordanian companies. For example, the Marketing Director said: " biosimilar technology is very expensive for any Jordanian company to aspire to develop it, as the technology costs millions and manufacturing costs millions ". Theme A.3 Human Resource and Knowledge Gaps There is a significant shortage of skilled personnel with biosimilar-specific experience in Jordan. Most firms depend on hiring expatriates or sending local staff abroad for training, which is costly and not scalable. The lack of in-house R&D capacity further limits technological self-sufficiency. Therefore, it can be concluded that the technological barrier is a main barrier in adopting biosimilars in developing countries. B. Organizational context Theme B.1 Inconsistent Management Commitment and Organizational Structure Support for biosimilar adoption varies across companies. Some firms demonstrate high-level management support and have structured units or project management offices (PMOs) to handle biosimilar projects. Others lack administrative clarity or a dedicated biosimilar team. Centralized decision-making is common, especially for tender-driven markets. As a vice president mentioned, “Most biosimilar product decisions are made by senior management because tenders are usually monitored and managed from the highest managerial level.” Indicating that there is an agreement that the firm’s characteristics, such as structure, management, and number of employees are not a barrier towards manufacturing biosimilars in developing countries. Theme B.2 Limited Financial and Organizational Resources Even when the interest exists, the high capital and operational costs deter investment. Slack resources such as underutilized personnel and departments could support biosimilar initiatives, but only within firms with proper planning. As Associate Director stated: “ it is necessary to bring in specialized experts and it can rely upon internally, but it is better to rely on experts coming from abroad .” Theme B.3 Communication and Cross-Functional Coordination According to the research, communication channels are available in JPCs and top companies in Jordan has Project Management Office, which help in communication coordination. For example, the Marketing Director stated, “ the company follows a PMO (Project Management Office) that coordinates communication with clear responsibilities and clear communication process .” However, communication is lacking in many organizations. Informal structures dominate, leading to loss of information and misalignment. Formalizing cross-departmental collaboration is seen as critical to biosimilar development, particularly for aligning medical, regulatory, and marketing strategies. Theme B.4 Strategic Agility and Innovation Orientation Agile decision-making and innovation were frequently ranked as critical by interviewees. Companies that can rapidly respond to changing market and regulatory conditions are better positioned to invest in biosimilars. As the marketing director explained, “ Agile decision making is the most important, followed by innovation and then resource allocation .” C. Environmental context Theme C.1 Regulatory Environment The Jordan Food and Drug Administration (JFDA) has adopted rigorous regulatory frameworks modeled after international standards. This promotes trust in Jordanian products but creates complex and lengthy approval processes. Clearer biosimilar-specific regulations are needed to facilitate local production. “JFDA is based on American and European procedures… there is a need to stand on the requirements for a Jordanian company to manufacture biosimilars,” stated a tender manager. Theme C.2 Market and Competitive Pressures Patent expirations, rising healthcare costs, and international competition (especially from India and China) are driving interest in biosimilars. However, the small size of the Jordanian market limits the commercial viability of large-scale investment. Most companies aim to penetrate Gulf markets where demand is higher. A marketing director observed, “If companies enter this field, the trend will be towards the Saudi market.” Theme C.3 Societal Trust and Market Acceptance Public and physician trust in locally produced biosimilars remains low but is improving. Government tenders and successful treatment outcomes are key to shifting perceptions. Ensuring product safety and building reputation are essential. “Now, recently, there is more confidence in local manufacturing at the level of regular medicines,” noted the tender manager. 4.2 Diffusion of Innovation (DOI) Theory Key Findings Theme D Limited Perceived Relative Advantage According to the literature, biosimilars have a relative advantage over biologics as their adoption leads to lower treatment bills. However, most interviewees were cautious about the relative advantage of biosimilars over biologics. Adoption is seen more as a cost-saving measure than an innovation strategy. The market-driven nature of biosimilar demand further weakens their perceived strategic value. “ It cannot be said that it has a relative advantage… each type has its own market ,” explained a tender manager. Theme E Compatibility with Existing Systems JPCs have good competencies that are compatible with biosimilars production, but it depends on how to utilize them. Existing systems in Jordanian firms are largely designed for generic drug production. Transitioning to biosimilars would require major infrastructural and procedural changes, posing compatibility challenges. The Associate Director highlighted, “ Regarding infrastructure, certainly not, but values yes .” The JFDA Director Manager stated, “ biosimilars production aligns with JPC’s existing values, practices, systems, and infrastructure .” Biosimilar production is still considered complex due to the precision required in manufacturing and regulatory compliance. This complexity discourages investment, especially from firms without prior biotechnological experience. “ This issue is a complex procedure, not a difficulty in manufacturing or development, but rather a difficulty in the infrastructure ,” stated the marketing director. Theme F High Complexity Biosimilars manufacturing is still considered complex due to the precision required in manufacturing, regulatory compliance, and needed infrastructure. The JFDA Director Manager stated, “ the unavailability of infrastructure is the main issue .” The Marketing Director confirmed by saying: “ this issue is a complex procedure, not a difficulty in manufacturing or development, but rather a difficulty in the infrastructure .” Theme G Low Trialability Opportunities to pilot biosimilar production are minimal due to the absence of specialized labs and funding. Trialability could accelerate adoption but is currently underdeveloped. The Marketing Director stated, “ JPCs have their own R&D departments, but there is no specialized lab or any lab to test biosimilars ”. Furthermore, The Associate Director said: “ if there is a test, adoption will be faster .” Theme H Moderate Observability Cost effectiveness and patient outcomes are the main observed benefits when products are included in tenders. However, more systematic tracking of outcomes and cost-savings is needed. The JFDA Director Manager said: “ the Jordanian biosimilar product will certainly be cheaper than the imported one and will save the treasury, especially with regard to tenders .” Table 1. presents a consolidated summary of how the study's research propositions align with the empirical evidence drawn from the thematic analysis. Each proposition—grounded in the TOE and DOI frameworks—is evaluated in terms of the level of support it received through interviews with stakeholders in the Jordanian pharmaceutical sector. Insert Table 1 about here. 4.3 Propositions Evaluation Based on Research Findings To assess the relevance and accuracy of the study’s conceptual framework, each of the eight research propositions developed under the Technology-Organization-Environment (TOE) and Diffusion of Innovation (DOI) frameworks was evaluated against the themes identified through qualitative analysis. Table 2. below presents a proposition-by-proposition assessment, indicating the level of empirical support and summarizing the key justifications drawn from interview data. This evaluation not only validates or refines the theoretical assumptions but also provides context-specific insights into the factors shaping biosimilar adoption in Jordan. Insert Table 2 about here. 5. Discussion 5.2 Technology-Organization-Environment (TOE) framework 5.2.1. Technological Factors For the Internal Technologies , the research demonstrates that Jordanian Pharmaceutical Companies prefer secondary packaging over biosimilar production. In contrast to international competitors, Jordan lacks the necessary technological know-how and infrastructure, which is consistent with the literature showing that adoption is hindered by technical barriers (Moorkens et al., 2017). Additionally, the literature highlights how internal technology capabilities aid in the adoption of innovations (Cruz-Jesus et al., 2019) and the limited internal technological capabilities can hinder the adoption of complex technologies (Al Teneiji et al., 2024) . For the External Technologies , the research shows that Jordanian pharmaceutical companies are forced to rely on outside partnerships since the cost of obtaining biosimilar manufacturing technologies is too high. This goes opposite to global trends that concentrate more on local production in emerging economies in an effort to lower imports (Leonard et al., 2019). The literature supports that external technology access is a critical factor in determining the adoption of biosimilars, especially in underdeveloped nations (Afshari-Mofrad & Salim, 2020). 5.2.2 Organizational Factors For Firm’s Characteristics , the research implies that organizational structure and firm size do not have a direct impact on the adoption of biosimilars. But investing in biosimilars is more common among pharmaceutical companies with established management systems. This is supported by literature, which highlights how companies with agile, yet hierarchical decision-making structures make it easier for new ideas to be adopted (Amini & Bakri, 2015; Zhu et al., 2006). For Resources , according to the research, two of the biggest challenges are a lack of specialized human resources and financial limitations. Even while some companies are interested, they are unable to allocate the required capital for the manufacturing of biosimilars due to considerable financial constraints. This is corroborated by the literature showing that significant R&D and workforce training expenditures are necessary for the successful adoption of biosimilars (Cruz-Jesus et al., 2019; Medlinskiene et al., 2021). For Communication Channels, the research emphasized that both formal and informal communication channels are essential for the acceptance of biosimilars. Nevertheless, research shows that interdepartmental communication is still challenging and often results in the loss of important information because of disorganized and unstructured procedures. The implementation of biosimilars might require a more specialized and organized approach, even though a Project Management Office structure is already in place to facilitate communication. According to the key stakeholders, a specialized biosimilar division or department would enhance coordination by ensuring that all teams—R&D, regulatory affairs, and marketing—work under a same plan (Al Teneiji et al., 2024; Salah & Ayyash, 2024). 5.2.3 Environmental Factors For Regulations, according to the research, Jordan's regulatory system is very supportive to the adoption of biosimilars, with specific guidelines that meet with international standards including EMA regulations. Stakeholders interviewed highlighted that the Jordan Food and Drug Administration (JFDA), which is renowned for its regulatory efficiency and clarity, has created one of the MENA region's most efficient and transparent regulatory regimes. This is consistent with literature showing that a clear regulatory framework is essential for speeding up the introduction of biosimilars onto the market while upholding strict safety and effectiveness requirements (Afshari-Mofrad & Salim, 2020). For Competition, local adoption is further constrained by competition from China and India, which makes it difficult for Jordanian Pharmaceutical Companies to invest in the manufacturing of biosimilars. Because they provide biosimilars at far reduced prices. Literature supports this, indicating that competition from global players impacts pricing strategies and market penetration for biosimilars (Kurki et al., 2021). For Societal Attitudes, research reveals that initial skepticism towards biosimilars may be observed among healthcare professionals and patients, but confidence in local pharmaceutical companies points to a promising future. which is consistent with literature that indicates biosimilar adoption is encouraged by public confidence in local pharmaceutical companies (Alawneh et al., 2022). Additionally, once biosimilars are widely accessible, skepticism tends to decrease (Gasteiger & Petrie, 2022; IQVIA, 2023). 5.3 DOI Theory For Relative Advantage, the research shows that biosimilars are a more affordable option than biologics, which is consistent with research showing that cost reductions and increased accessibility are important factors in the uptake of biosimilars (Shaina Shah & Pranav Patel, 2022). Furthermore, financial gain, potential savings of 20–30%, is a major motivator for adoption, supporting international research highlighting the economic advantages of biosimilars (Ghaleb et al., 2021; Medlinskiene et al., 2021). For Complexity, the research shows that the creation of biosimilars is thought to be extremely complicated because of production and regulatory issues. This is supported by literature, which highlights the need for advanced infrastructure and knowledge due to the technical complexity of new technology (Afshari-Mofrad & Salim, 2020). For Compatibility, according to the research, the degree to which biosimilars fit with current production capacities, regulations, and healthcare practices determines how widely they are adopted by Jordanian pharmaceutical companies. The findings show that although Jordan's clinical and regulatory systems are favorable, local pharmaceutical companies have difficulties incorporating biosimilars into their current supply chains and production processes. For seamless integration into treatment regimens, healthcare personnel also need further training. Adoption may be slowed by the gap between present capabilities and the need for producing biosimilars unless companies make investments in workforce development and technological adaption (Afshari-Mofrad & Salim, 2020; IQVIA, 2023). For Trialability, the research shows that while biosimilars are subject to case studies prior to being included in government tenders, this only applies to biosimilars that already have FDA approval. Because the current facilities have been constructed for generic molecules and are not appropriate for biosimilars, Jordan lacks specializing laboratories for biosimilar trialability. This is corroborated by literature, which shows that one important consideration is the capacity to test novel treatments before their widespread adoption (Gerard Quinn, 2024). For Observability, according to the research, the adoption of biosimilars is encouraged by financial savings and favorable patient outcomes. Literature demonstrates that tangible advantages promote market adoption and government approval (IQVIA, 2023; Scott Morton et al., 2018). 6. Conclusion and implications This study presents a comprehensive examination of the factors influencing the adoption of biosimilars in Jordanian Pharmaceutical Companies by combining the Diffusion of Innovation (DOI) theory with the Technology-Organization-Environment (TOE) framework, this provides comprehensive understanding of both internal and external factors influencing the adoption of biosimilars. From technological perspectives, the lack of internal technology abilities and limited access to external technologies, expertise and know-how are major barriers to biosimilars adoption. Currently, Jordanian pharmaceutical companies use secondary packaging over full-scale biosimilar production, due to complexity (internal factors) studied through the DOI theory which consider the biosimilar production a complex process due to unavailability of internal technologies, lack of experience and the know-how. From organizational perspectives, firm’s characteristics are not a major factor for biosimilar production, although its reputation and size may facilitate the adoption, the management system and top management support remains the key factors relating to this, on the other hand, even the JPCs have good human resources, they lack biosimilar related experience, this shows a barrier for biosimilar adoption. Although the top management determines the economic benefits and the positive impact of biosimilar production on company’s market presence, JPCs prefer to use secondary packaging over full-scale biosimilar production, as the lack of infrastructure makes the company’s resources incompatible with biosimilars production resources, lack of expertise and specialized trial laboratory, make the relative advantage unclear for them. These internal factors (Relative Advantage, Compatibility and Trialability) studied through the DOI theory. From organizational perspectives, although regulations in Jordan are very supportive to biosimilars’ adoption, nonetheless, competition from Indian and Chinese companies form a threat for this large investment, in addition to expected initial societal attitudes of skepticism limit the observable benefits of biosimilars production in JPCs. 6.1Theoretical Contribution This study enhances the theoretical framework of biosimilar adoption by applying the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to the pharmaceutical sector in a developing market. This research offers a fresh viewpoint on biosimilar adoption by applying established frameworks to Jordan, a country characterized by distinct legal and economic factors. The study contributes to the TOE framework by revealing the interaction of technological, organizational, and environmental factors in influencing biosimilar adoption. It emphasizes that although regulatory support is present, technological, and financial limitations surpass its benefits, making adoption complicated. In addition, the finding contribute to the TOE model by highlighting the significance of technological and financial accessibility in pharmaceutical contexts. The application of DOI theory to the adoption of biosimilars illustrates how factors like relative advantage, complexity, compatibility, trialability, and observability influence adoption options. Despite the clear relative advantage and cost-effectiveness, the perceived complexity of biosimilars continues to be a substantial barrier. This research indicates that DOI theory must consider the significant regulatory compliance associated with biosimilars, distinguishing them from other innovations. Finally, this research contributes to the literature by offering empirical data that supports the integration of the TOE and DOI frameworks, illustrating their complimentary functions in understanding the adoption of complicated pharmacological innovations. 6.2 Practical Implications The findings of this research contain significant importance for stakeholders such as legislators, pharmaceutical companies, and healthcare professionals in Jordan and similar developing nations. The research highlights the necessity for authorities to establish enhanced financial incentives and infrastructure to promote local biosimilar production. Although regulatory systems comply with international standards, supplementary measures like subsidies, tax incentives, and investment in research and development can facilitate adoption. Establishing specialized biosimilar trial laboratories in Jordan could reduce reliance on international testing facilities and enhance trialability for local companies. Additionally, this research underscores the significance of partnerships between pharmaceutical companies and global biosimilar manufactures. Due to the substantial costs and technological barriers linked to biosimilar production, collaborating with multinational companies can enhance the know-how information exchange, increase technology accessibility, and minimize financial risks. Moreover, companies have to evaluate investing in specific training programs to cultivate internal knowledge and address the existing skills deficit in biosimilar production. Healthcare professionals and organizations must contribute to enhancing biosimilar adoption by reducing skepticism and eliminating misconceptions. Educational programs aimed at healthcare providers and patients can foster trust in biosimilars and improve their acceptance. Training initiatives, workshops, and case studies emphasizing the efficacy and safety of biosimilars can enhance their observability and promote greater adoption. 6.3 Limitations and Future Studies The qualitative, cross-sectional design of the research makes it difficult to track long-term trends in the adoption of biosimilars. Further longitudinal research may provide more in-depth understanding of Jordan's changing market and regulatory conditions Furthermore, the non-probability sample design and the sample size limits broad generalizations even though it is enough for qualitative analysis in exploratory studies. Future research may suggest alternative outcomes if the participant pool is expanded to include a wider variety of stakeholders, including legislators and medical professionals for example. Finally, future research can focus on assessing the financial effects of adopting biosimilars, policy-oriented economic studies have to be carried out. 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HCP Live. https://www.hcplive.com/view/biosimilars-saved-12-3-billion-2023-fraction-potential-savings Kamble, S., Gunasekaran, A., & Arha, H. (2019). Understanding the blockchain technology adoption in supply chains—Indian context. International Journal of Production Research, 57(7), 2009–2033. https://doi.org/10.1080/00207543.2018.1518610 Katsanis, L. P., Pitta, D., & Morinville, A. (2021). Patient centricity: Lip service or genuine commitment? A qualitative examination of the pharmaceutical industry. International Journal of Pharmaceutical and Healthcare Marketing, 15(1), 106–133. https://doi.org/10.1108/IJPHM-02-2020-0010 Kurki, P., Barry, S., Bourges, I., Tsantili, P., & Wolff-Holz, E. (2021). Safety, immunogenicity and interchangeability of biosimilar monoclonal antibodies and fusion proteins: A regulatory perspective. Drugs, 81(16), 1881–1896. https://doi.org/10.1007/s40265-021-01601-2 Leonard, E., Wascovich, M., Oskouei, S., Gurz, P., & Carpenter, D. (2019). 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HCI and technology adoption in healthcare. In Machine learning approaches and applications in applied intelligence for healthcare data analytics (pp. 191–200). CRC Press. https://doi.org/10.1201/9781003132110-12 Mishra, S. B., & Alok, S. (2017). Handbook of research methodology. Retrieved from https://www.researchgate.net/publication/319207471 Moorkens, E., et al. (2017). Policies for biosimilar uptake in Europe: An overview. PLoS ONE, 12(12). https://doi.org/10.1371/journal.pone.0184782 MS Pharma. (2024). FYB201/Ranibizumab keeps gaining momentum with approvals and launches in the MENA region. https://www.mspharma.com/en/fyb201-ranibizumab-keeps-gaining-momentum-with-approvals-and-launches-in-the-mena-region Mujalli, A., Wani, M. J. G., Almgrashi, A., Khormi, T., & Qahtani, M. (2024). Investigating the factors affecting the adoption of cloud accounting in Saudi Arabia’s small and medium-sized enterprises (SMEs). Journal of Open Innovation: Technology, Market, and Complexity, 10(2). https://doi.org/10.1016/j.joitmc.2024.100314 Nam, K., Dutt, C. S., Chathoth, P., Daghfous, A., & Khan, M. S. (2021). The adoption of artificial intelligence and robotics in the hotel industry: Prospects and challenges. Electronic Markets, 31(3), 553–574. https://doi.org/10.1007/s12525-020-00442-3 Ninčević Pašalić, I., & Ćukušić, M. (2024). Understanding E-participation adoption: Exploring technological, organizational, and environmental factors. Technological Forecasting and Social Change, 207, 123633. https://doi.org/10.1016/j.techfore.2024.123633 Parmachoices. (2024). Full list of pharmaceutical companies in Jordan. Pharmchoices. https://pharmchoices.com/full-list-of-pharmaceutical-companies-in-jordan/ Prasad Agrawal, K. (2024). Towards adoption of generative AI in organizational settings. Journal of Computer Information Systems, 64(5), 636–651. https://doi.org/10.1080/08874417.2023.2240744 Priyarega, S., & Natarajan, R. (2022). An overview of biosimilars for cancer, diabetes mellitus, rheumatoid arthritis and other immune-mediated diseases approved between 2016 and 2021. Results in Chemistry, 4, 100356. https://doi.org/10.1016/j.rechem.2022.100356 Qatawneh, N. (2024). Empirical insights into business intelligence adoption and decision-making performance during the digital transformation era: Extending the TOE model in the Jordanian banking sector. Journal of Open Innovation: Technology, Market, and Complexity, 10(4), 100401. https://doi.org/10.1016/j.joitmc.2024.100401 Quinn, G., & B., P. B. (2024). Combating barriers to biosimilar use. U.S. Pharmacist, 28–34. https://www.uspharmacist.com/article/combating-barriers-to-biosimilar-use Qutaishat, F., Abushakra, A., Anaya, L., & Al-Omari, M. (2023). Investigating the factors affecting the intention to adopt cloud-based ERP systems during the COVID-19 era: Evidence from Jordan. Business Process Management Journal, 29(3), 653–670. https://doi.org/10.1108/BPMJ-09-2022-0462 Rehman, A., Awan, M. A., Ahmad, M., Shahid, M. N., Shahzad, A., & Kamran, M. (2024). Drivers of metaverse adoption for enhancing marketing capabilities of retail SMEs. Technology in Society, 79, 102704. https://doi.org/10.1016/j.techsoc.2024.102704 Reichert, J. M. (2003). Trends in development and approval times for new therapeutics in the United States. Nature Reviews Drug Discovery, 2(9), 695–702. https://doi.org/10.1038/nrd1178 Rogers, E. M. (2003). Diffusion of innovations (5th ed.). Free Press. https://www.google.jo/books/edition/Diffusion_of_Innovations_5th_Edition/9U1K5LjUOwEC?hl=en&gbpv=1&kptab=overview Rouidi, M., Elouadi, A., & Hamdoune, A. (2022). Acceptance and use of telemedicine technology by health professionals: Development of a conceptual model. Digital Health, 8. https://doi.org/10.1177/20552076221081693 Saeed, H., Bin Rashid, M., Som, H. M., Mahmood, R., & Hamid, H. (2023). Organizational innovation and leadership styles in healthcare with the mediating role of organizational culture. Journal of Health Administration, Winter 2023(4). https://www.researchgate.net/publication/370265548 Salah, O. H., & Ayyash, M. M. (2024). E-commerce adoption by SMEs and its effect on marketing performance: An extension of TOE framework with AI integration, innovation culture, and customer tech-savviness. Journal of Open Innovation: Technology, Market, and Complexity, 10(1), 100183. https://doi.org/10.1016/j.joitmc.2023.100183 Saunders, M. N. K. (2023). Research methods for business students. Scott Morton, F. M., Stern, A. D., & Stern, S. (2018). The impact of the entry of biosimilars: Evidence from Europe. Review of Industrial Organization, 53(1), 173–210. https://doi.org/10.1007/s11151-018-9630-3 Shah, S., & Patel, P. M. (2022). Biosimilar adoption: Patient and provider considerations. Pharmacy Times. https://www.pharmacytimes.com/view/biosimilar-adoption-patient-and-provider-considerations Thomas, J., & Harden, A. (2008). Methods for the thematic synthesis of qualitative research in systematic reviews. BMC Medical Research Methodology, 8, Article 45. https://doi.org/10.1186/1471-2288-8-45 TOPRA. (2019, February). Biosimilar products: Regulatory complexities and challenges of biosimilars. CPD Supplement, Regulatory Rapporteur. The Organisation for Professionals in Regulatory Affairs (TOPRA). Retrieved from https://www.topra.org/CPDsupplements U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), & Weiner, J. (2015). Biosimilars: Questions and answers regarding implementation of the Biologics Price Competition and Innovation Act of 2009 – Guidance for industry. U.S. Food and Drug Administration. (n.d.). Overview of biosimilar products. https://www.fda.gov/biosimilars U.S. Generic and Biosimilar Savings Report: Biosimilars deliver on their promise, 2023. (2023). Biosimilars Council. https://biosimilarscouncil.org/resource/2023-us-generic-biosimilar-savings-report Valencia-Arias, A., Gallegos, A., Aliaga Bravo, V. D. C., Victoria Mori, F. L., Uribe-Bedoya, H., & Palacios-Moya, L. (2024). Understanding telemedicine adoption: Evidence, gaps, and future perspectives for sustainable healthcare. Cogent Social Sciences, 10(1), 2306712. https://doi.org/10.1080/23311886.2024.2306712 Yang, J., Blount, Y., & Amrollahi, A. (2024). Artificial intelligence adoption in a professional service industry: A multiple case study. Technological Forecasting and Social Change, 201, 123251. https://doi.org/10.1016/j.techfore.2024.123251 Yin, R. K. (2002). Case study research: Design and methods (3rd ed., Vol. 5). Zhong, Y., & Moon, H. C. (2023). Investigating the impact of Industry 4.0 technology through a TOE-based innovation model. Systems, 11(6). https://doi.org/10.3390/systems11060277 Zhu, K., Kraemer, K. L., & Xu, S. (2006). The process of innovation assimilation by firms in different countries: A technology diffusion perspective on e-business. Management Science, 52(10), 1557–1576. https://doi.org/10.1287/mnsc.1050.0487 Table Table 1 is available in the Supplementary Files section Additional Declarations The authors declare no competing interests. Supplementary Files Table1Summaryofthematicanalysis.sourceauthorswork.png Summary of the thematic analysis Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-6899804","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":471551423,"identity":"9797f2b9-68f9-431c-a375-a1911f3956b7","order_by":0,"name":"Dunia Alqadi","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA4UlEQVRIiWNgGAWjYBACNnYgwWPAzMDAzMD4gIHhAGEt/MwILcwGRGmRbAZpYWAG2yhBlBaDw8wbP7wpsE7czs78rJqn5o4cPwPzw0c38GphK5acY5CeuLOZzew2z7FnxpINbMbGOXi18BhI8xgcTtxwmAGohQ3IOMDDJo1Pi/1hHuPfEC3s34p5/hGhBWiLGdQWHjNm3jaitLCVWQL9YgzUUiw5t++wsWQzIb8cb958480fa9kN548Dg+7bYTl+9uaHj/FpAemCs5h4QCQzfuWoWhh/EFY9CkbBKBgFIxAAAOxJTISpq+p5AAAAAElFTkSuQmCC","orcid":"https://orcid.org/0009-0008-1400-8106","institution":"GJU","correspondingAuthor":true,"prefix":"","firstName":"Dunia","middleName":"","lastName":"Alqadi","suffix":""},{"id":471551424,"identity":"faac3156-fa1a-4400-9fc9-0ba6edd78d29","order_by":1,"name":"Aziz Madi","email":"","orcid":"","institution":"GJU","correspondingAuthor":false,"prefix":"","firstName":"Aziz","middleName":"","lastName":"Madi","suffix":""}],"badges":[],"createdAt":"2025-06-15 18:28:06","currentVersionCode":1,"declarations":{"humanSubjects":false,"vertebrateSubjects":true,"conflictsOfInterestStatement":false,"humanSubjectEthicalGuidelines":false,"humanSubjectConsent":false,"humanSubjectClinicalTrial":false,"humanSubjectCaseReport":false,"vertebrateSubjectEthicalGuidelines":true},"doi":"10.21203/rs.3.rs-6899804/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6899804/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":85302685,"identity":"0fb6e507-941c-421e-bf69-949a66958d9f","added_by":"auto","created_at":"2025-06-24 12:20:36","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":28032,"visible":true,"origin":"","legend":"\u003cp\u003eillustrates the theoretical model for biosimilar adoption, which combines Technological-Organizational-Environmental \u003cstrong\u003e(TOE) \u003c/strong\u003eframework\u003cstrong\u003e \u003c/strong\u003eand\u003cstrong\u003e \u003c/strong\u003eDiffusion of Innovation \u003cstrong\u003e(DOI) \u003c/strong\u003etheory.\u003c/p\u003e","description":"","filename":"Figure1TheoreticalModelforBiosimilarAdoption.png","url":"https://assets-eu.researchsquare.com/files/rs-6899804/v1/d50fa504c37d5cad2f105e12.png"},{"id":85303799,"identity":"f1093549-9c50-47f4-bf22-78fcedbab27a","added_by":"auto","created_at":"2025-06-24 12:28:36","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1017677,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6899804/v1/bf99e235-e087-4944-b0cd-b963380ff051.pdf"},{"id":85302686,"identity":"42df3f6a-7b5f-4589-b15d-7d873b26eb53","added_by":"auto","created_at":"2025-06-24 12:20:37","extension":"png","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":36422,"visible":true,"origin":"","legend":"\u003cp\u003eSummary of the thematic analysis\u003c/p\u003e","description":"","filename":"Table1Summaryofthematicanalysis.sourceauthorswork.png","url":"https://assets-eu.researchsquare.com/files/rs-6899804/v1/831e14fe49e32b5e0ab298c4.png"}],"financialInterests":"The authors declare no competing interests.","formattedTitle":"\u003cp\u003e\u003cstrong\u003eUnderstanding the factors influencing the adoption of biosimilars; an innovation theory perspective\u003c/strong\u003e\u003c/p\u003e","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eAccording to estimates, the worldwide biosimilar industry is expected to develop at a compound annual growth rate (CAGR) of 30.9%, reaching USD 60\u0026nbsp;billion by 2025 (Priyarega \u0026amp; Natarajan, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2022\u003c/span\u003ea). With cumulative sales are predicted to reach USD 129\u0026nbsp;billion over the following five years. (IQVIA, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003cp\u003e Currently, \u003cspan\u003e$\u003c/span\u003e38\u0026nbsp;billion is spent on molecules that are up against biosimilar competition, and an additional \u003cspan\u003e$\u003c/span\u003e96\u0026nbsp;billion is anticipated to be spent on biologics that will join the biosimilar market. The same research states that IQVIA predicts that by 2027, biosimilar spending in the United States will have increased significantly, establishing biosimilars as affordable options for the treatment of complicated and chronic illnesses (IQVIA, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2023\u003c/span\u003e ). \u003c/p\u003e \u003cp\u003eAmong the key factors that are driving biosimilar growth worldwide is the rising chronic disease prevalence, the demand of an expanding patient base, significant financial savings for healthcare systems, enhanceed patient accessibility (as biosimilars are usually 20%-30%% less expensive than their reference biologics), favorable regulatory changes, and patent expirations of major biologics that opens the market for biosimilar competitions ((IQVIA, \u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e2023\u003c/span\u003e; Priyarega \u0026amp; Natarajan, \u003cspan citationid=\"CR44\" class=\"CitationRef\"\u003e2022\u003c/span\u003e; Gherghescu \u0026amp; Delgado-Charro, 2021); Kurki et al., \u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e2021\u003c/span\u003e). However, despite the excellent clinical efficacy of these treatments, a number of obstacles have prevented their widespread use, including regulatory obstacles, patient misunderstandings, and healthcare professional distrust. (Afshari-Mofrad \u0026amp; Salim, \u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e2020\u003c/span\u003e; Ghaleb et al., \u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003cdiv class=\"BlockQuote\"\u003e\u003cp\u003eCurrent research on the adoption of biosimilars frequently concentrates on discrete elements. For example, a systematic review by Leonard et al. (\u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e2019\u003c/span\u003e) showed that a major obstacle to the prescription of biosimilars is the lack of information and concerns regarding safety and efficacy among healthcare practitioners (Leonard et al., \u003cspan citationid=\"CR31\" class=\"CitationRef\"\u003e2019\u003c/span\u003e). Moorkens et al. (2020) examined European biosimilar adoption policies, focusing on how pricing, market incentives, and bidding procedures affect adoption. These studies, however, only look at particular aspects of the adoption process; they don't take into account the organizational, technical, and environmental elements that influence how biosimilars are implemented in various markets (Moorkens et al., \u003cspan citationid=\"CR37\" class=\"CitationRef\"\u003e2017\u003c/span\u003e).\u003c/p\u003e\u003cp\u003eFurthermore, no comprehensive research has systematically examined the variables influencing the adoption of biosimilars in developing countries, where the health care systems and patients can represent a perfect alignment for a cost efficient solution. There is a significant knowledge gap in how pharmaceutical firms, healthcare providers, and policymakers manage the introduction of biosimilars because the majority of existing papers concentrate on biosimilar rules rather than adoption drivers (Al-ali Malkawi et al., \u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e2018\u003c/span\u003e; Haddadin, \u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e2011\u003c/span\u003e)\u003c/p\u003e\u003cp\u003eIn order to address this gap, this research uses the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to systematically analyze biosimilar adoption in Jordan. The TOE framework provides an in-depth evaluation of the technological, organizational, and environmental factors that affect the adoption of biosimilars. At the same time, DOI theory makes it easier to analyze how biosimilars diffuse throughout stakeholders, emphasizing important factors as relative advantage, compatibility, trialability, complexity, and observability. By combining these frameworks, the research seeks to give policymakers, healthcare professionals, and industry stakeholders a comprehensive knowledge of biosimilar adoption and useful advice on how to increase biosimilar market penetration in Jordan.\u003c/p\u003e\u003c/div\u003e\u003c/p\u003e \u003cp\u003eThis study aims to investigate and evaluate the key factors of biosimilar adoption in Jordanian pharmaceutical companies. Using the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory, the study attempts to offer a systematic understanding of the technological, organizational, and environmental factors, as well as the innovation-specific traits that influence the adoption of biosimilars. From the viewpoints of regulatory bodies and stakeholders in the pharmaceutical sector, this study aims to identify adoption facilitators and barriers. In doing so, this study has the following research question: RQ1: \u003cem\u003eWhat factors could facilitate a successful adoption of biosimilar manufacturing in Jordanian pharmaceutical companies?\u003c/em\u003e\u003c/p\u003e \u003cp\u003eBy answering the research question, this study introduce several theoretical and practical contributions. This research applies the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to the adoption of biosimilars, although these frameworks have been extensively employed in research on technology adoption, little is known about how they may be applied in the biosimilar industry, especially in a developing country like Jordan. Additionally, this study fills a gap in the literature on the adoption of biosimilars in developing markets, since the majority of previous research has been on developed economies. This expansion increases these theories' generalizability and increases their applicability in many regulatory and healthcare sectors.\u003c/p\u003e \u003cp\u003eAs for the practical contributions of this research, it offers evidence-based suggestions for healthcare institutions to accelarete the adoption of biosimilars in developing countries, in addition, regulatory authorities can accelerate approval processes and ease the introduction of biosimilars into the market. Pharmaceutical firms can understand the important technological, organizational and environmental factors that may increase their competitiveness and enhance their adoption strategy. And finally, medical professionals may learn more about the elements that affect the acceptability of biosimilars, and the factors that will lead to the adoption, which will eventually improve patient access to reasonably priced treatments.\u003c/p\u003e \u003cp\u003eThe structure of this study unfolds as follows: it begins with a review of relevant literature, followed by a detailed explanation of the research methodology. The subsequent section presents the findings from the interviews, from which key themes are derived. These findings are then discussed in depth in the discussion section. The study concludes by outlining its theoretical and practical implications, acknowledging its limitations, and offering recommendations for future research.\u003c/p\u003e"},{"header":"2. Literature Review","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\n \u003ch2\u003e2.1 Theoretical Framework\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eTo understand the factors influencing biosimilar adoption, this research applies two theoretical models: the Technology-Organization-Environment (TOE) Framework and the Diffusion of Innovation (DOI) Theory. Each model offers a unique lens through which to analyze the variables that shape adoption, covering both the technological, organizational, and environmental elements, as well as the social dynamics within healthcare settings that influence the acceptance of new technologies such as biosimilars (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec4\" class=\"Section3\"\u003e\n \u003ch2\u003e2.1.1 Technology-Organization-Environment (TOE) Framework\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe Technology-Organization-Environment (TOE) framework, developed by Tornatzky and Fleischer in 1990 (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e, Tronatzky and Fleishcer (1990), classifies the factors of an enterprise that influence the adoption of innovation into three factors: Technological, Organizational, and Environmental. This model has been widely applied in healthcare to understand how firms adopt innovation by highlighting both internal and external factors (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Mujalli et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Qatawneh, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Yang et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eTechnological, organizational, and environmental factors can include several factors according to the theory. Technological factors refer to the firm\u0026rsquo;s relevant internal and external technologies, in addition to those that are accessible for adoption. Organizational factors refer to the descriptive characteristics of the firm (such as organizational structure, firm size, managerial structure, and degree of centralization), its resources (human and slack resources), and the formal and informal channels of employee communication. Environmental factors include the market elements, competitors, and the regulatory environment. (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e), hereafter is the explanation of these factors and how they can be related to biosimilars.\u003c/p\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec5\" class=\"Section4\"\u003e\n \u003ch2\u003e2.1.1.1. Technological Factors\u003c/h2\u003e\n \u003cp\u003eWithin the TOE (Technology-Organization-Environment) framework, technological factors refer to all the internal and external relevant technology of an organization, both the present internal technology accessible inside the organization, and other available external technologies, i.e., those that are available outside but not adopted yet by the organization (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e). In this context, however, one might usefully think of technology in material (e.g., equipment) and/or immaterial (e.g., data and methods in use). The technological factors separated to highlight focus on how attributes of the technology itself drive adoption decision. These factors provide insight into the potential benefits and challenges organizations might experience when adopting new innovations (Tornatzky \u0026amp; Fleischer (1990), (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e)).\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eWithin the healthcare domain, several studies emphasized that technological factors play a crucial role in impacting innovation adoption. Cruz-Jesus et al. (\u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e) highlighted the importance of technological characteristics, including compatibility, complexity, and relative advantages, in determining adoption levels for CRM technologies stages which facilitated their uptake as innovations. Similarly, Ghaleb et al. (\u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e) investigated healthcare employees\u0026apos; readiness to adopt big data technologies based on the TOE framework with a particular focus on alignment of technological advance with organizational readiness in facilitating innovation. Furthermore, in the study on e-participation adoption by Pa\u0026scaron;alić and Ćuku\u0026scaron;ić (2024) have noted that especially facilitate technological factors like system reliability or ease of use makes a large contribution to the successful organizational adoption of innovations. Together, these findings elaborate that technological factors play an essential role in innovation adoption, both within and outside the healthcare sector.\u003c/p\u003e\n \u003cp\u003eThese factors are operationalized in this research as the availability of manufacturing technology, whether internally available or externally accessible, by the Jordanian pharmaceutical companies. Therefore, this research proposes the following:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP1: The technological factors, if available, play a key role in Jordanian pharmaceutical companies to adopt biosimilars manufacturing.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec6\" class=\"Section4\"\u003e\n \u003ch2\u003e2.1.1.2. Organizational Factors\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe TOE framework\u0026apos;s organizational factors refer to the descriptive characteristics of the firm (such as organizational structure, firm size, managerial structure, and degree of centralization), its resources (human and slack resources), and the formal and informal channels of employee communication (Tronatzky and Fleishcer (1990), Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e). Another important factor that might help or hinder the adoption of an invention is the support of top management. Multiple opinions exist about the function of slack resources inside companies. Even though businesses want to have slack, this does not always help the adoption process. There is currently no clear correlation between size and adoption rate, nor is the function of scale in embracing innovations fully recognized (Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e; Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e)\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eThe Firm\u0026rsquo;s Characteristics\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe firm\u0026rsquo;s characteristics in this context refer to \u003cem\u003eorganizational structure, firm size, managerial structure, and degree of centralization\u003c/em\u003e ,(Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e p.124)\u003c/p\u003e\n \u003cp\u003eThese characteristics are identified as essential factors in the innovation adoption process (Qatawneh, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Salah \u0026amp; Ayyash, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Zhong \u0026amp; Moon, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). The organizational structure can facilitate or obstruct the adoption of new technologies, particularly in specialized sectors. Large companies often have superior resources and well-defined management frameworks, enabling more effective decision-making and resource distribution (Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e; Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e). Nevertheless, certain organizations must implement a level of centralization, as excessive decision-making by subsidiaries might hinder the adoption of innovations (Qatawneh, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). The healthcare sector\u0026apos;s adoption of new technologies often depends on interdepartmental collaboration, highlighting the necessity of adaptable organizational structures (DiMasi et al., \u003cspan class=\"CitationRef\"\u003e2016\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e). This research operationalized the firm\u0026apos;s distinctive elements, including organizational structure, firm size, management structure, and degree of centralization.\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eThe Firm\u0026rsquo;s Resources\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe firm\u0026rsquo;s resources in this context refer to \u003cem\u003ehuman and slack resources\u003c/em\u003e (Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e, p. 124).\u003c/p\u003e\n \u003cp\u003eHuman resources, containing skilled employees and expertise, are essential for the management and execution of new initiatives in biotechnology. The availability of skilled professionals in the healthcare industry substantially influences the effectiveness of biopharmaceutical efforts (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e). Slack resources, characterized as the excess resources available beyond operational requirements, provide firms with the opportunity to invest in innovation. Slack resources enable firms to allocate funds toward research, development, and regulatory compliance, which are critical components of the adoption process for new medicines. These resources help overcome financial barriers and facilitate the integration of innovative treatments into clinical practice (Reichert, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e; Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e). This research defines the firm\u0026apos;s resources as human and slack resources. Human resources include the skills, expertise, and training of workers involved in production. Slack resources indicate surplus financial, technical, or operational assets that offer flexibility for investment in innovation, research, and adherence to regulatory requirements (Qatawneh, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eThe Firm\u0026rsquo;s Channels of Communication\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eThe firm\u0026rsquo;s communication channels in this context refer to the formal and informal channels of employee communication (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eBoth formal and informal communication channels are critical to ensure a culture of innovation and receptiveness towards technology adoption. Formal methods, including scheduled meetings, reports, and hierarchical communications, facilitate clear guidance and responsibility in the process of innovation. Informal methods, such as individual conversations and cross-departmental collaborations, facilitate the transfer of unspoken knowledge and foster creative problem-solving, which are crucial in the dynamic manufacturing sector (Salah \u0026amp; Ayyash, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Zhong \u0026amp; Moon, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). Research in the healthcare industry suggests that teams need to communicate effectively to alleviate concerns and share best practices when carrying out active innovations (Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Greenhalgh et al., \u003cspan class=\"CitationRef\"\u003e2004\u003c/span\u003e; Raymond K. Cross et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e). The firm\u0026rsquo;s communication are operationalized in this research as both formal and informal communication. Formal channels refer to structured meetings, reports, and hierarchical communications. Informal channels refer to peer-to-peer interactions and cross-departmental collaborations.\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eTop Management Support\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe role of top management support is very critical in acting as an enabler to innovation adoption. Innovative leaders create a culture of innovation within their organizations, providing capital and resources while minimizing the resistance to change. In the healthcare sector, managerial assistance is crucial for overcoming obstacles to the implementation of breakthrough therapies and fostering collaboration across teams. The commitment of senior management is essential for cultivating an organizational culture that emphasizes continuous improvement and aligns the implementation of innovation with overarching objectives, such as cost reduction and improved patient outcomes (Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Saeed et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). The top management support is operationalized in this research as the active role of senior leaders in promoting Biosimilar adoption.\u003c/p\u003e\n \u003cp\u003eBased on that, this research proposed the following:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP2: The current organizational factors in Jordanian pharmaceutical companies support the adoption of manufacturing biosimilars.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec7\" class=\"Section4\"\u003e\n \u003ch2\u003e2.1.1.3 Environmental Factors:\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eEnvironmental factors, including regulatory requirements, competitive pressures, and societal attitudes, profoundly impact the biosimilar adoption scenario. Beneficial laws and streamlined approval procedures diminish entry barriers, promoting the incorporation of biosimilars into clinical practice for healthcare organizations. Regulatory frameworks governing patent expirations and fostering competition\u0026mdash;especially in countries with evolving legislation like India\u0026mdash;significantly bolster the growth of the biosimilar business by enabling the swift launch of affordable alternatives (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Priyarega \u0026amp; Natarajan, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003ea)\u003c/p\u003e\n \u003cp\u003eThe rivalry within the pharmaceutical sector, intensified by the emergence of several biosimilar alternatives, diminishes prices, hence improving accessibility for healthcare providers and patients. This market-oriented cost decrease enhances the appeal of biosimilars, particularly in economically sensitive healthcare settings. Moreover, societal attitudes, encompassing the viewpoints of patients and healthcare workers, are crucial for acceptance. Educational programs addressing psychological hurdles, such as the nocebo effect, are essential for enhancing acceptance, since they reduce uncertainty about the efficacy and safety of biosimilars. The TOE framework proposes that external environmental factors are crucial determinants that can either facilitate or obstruct the adoption of biosimilars in healthcare contexts, based on existing regulatory, market, and societal dynamics (Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eRegulatory Requirements\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eRegulatory requirements are critical factors in the adoption of biosimilars, as it encompasses policies, guidelines, and approval processes established by government bodies to regulate biosimilar entry and usage. Establishing regulatory standards, streamlining approval procedures, and providing instructions on interchangeability can facilitate the smooth incorporation of biosimilars into healthcare systems. Countries with advantageous rules, such as those inside the European Union, frequently see heightened biosimilar adoption owing to well delineated criteria and expedited licensing procedures (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e). However, countries with rigorous or undefined regulatory frameworks may have decreased adoption rates due to increased market entry barriers (Regulatory Complexities and Challenges of Biosimilars, 2019). This research put into practice the regulatory requirements concerning the perception of policies, guidelines, and approval processes set by governmental entities, and whether these are perceived as supportive or restrictive to the adoption of biosimilars.\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eCompetitive Pressures\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eCompetitive pressure reflects the influence of market dynamics and competition on the uptake of biosimilars. Following the expiry of patents for reference biologics, biosimilars enter the market, enhancing competition that encourages price reductions and cost-saving measures for healthcare providers. In areas with several biosimilar options, increased competition often lowers prices, improving the accessibility and appeal of biosimilars for healthcare systems and patients (IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e). This rivalry prompts healthcare professionals to regard biosimilars as a viable option to pricier biologics, particularly in cost-sensitive healthcare environments. The competitive pressures in this reasearch are be operationalized as the availability of multiple biosimilar alternatives available to pharmaceutical companies in Jordan.\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eSocietal Attitudes\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eSocietal Attitudes encompass the perceptions and acceptance levels of biosimilars among patients, healthcare providers, and the general public. Acceptance is sometimes influenced by variables such as the nocebo effect (where adverse expectations diminish perceived treatment efficacy), disinformation, or inadequate understanding of the safety and effectiveness of biosimilars (Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Raymond K. Cross et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e). Favorable public perceptions, cultivated via education and awareness initiatives, can augment trust in biosimilars, hence promoting their integration into treatment protocols. Confronting these views is crucial, since opposition or mistrust from patients and healthcare professionals may obstruct the incorporation of biosimilars in healthcare environments (Gerard Quinn, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). This research operationalizes social views as the perceptions and acceptance levels of biosimilars among patients and healthcare providers.\u003c/p\u003e\n \u003cp\u003eBased on that, this research proposes the following:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP3: The environmental factors in Jordanian pharmaceutical market are supportive to adoption of biosimilars manufacturing.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n \u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\n \u003ch2\u003e2.1.2 Diffusion of Innovation (DOI) Theory\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eDiffusion of Innovation (DOI) Theory offers a comprehensive framework for understanding how new ideas, technologies, or practices spread through social systems. Established by Everett Rogers in 1962, the Diffusion of Innovations (DOI) theory defines key factors influencing the rate of adoption and integration of innovations within companies and among individuals (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e). Within the field of healthcare, DOI theory clarifies the factors that affect the acceptability and adoption of biosimilars, an innovative category of biologics intended to deliver comparable effectiveness and safety profiles to reference biologics while being more cost-effective (Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eDOI theory\u0026rsquo;s factors\u0026mdash;\u003cstrong\u003eRelative Advantage, Compatibility, Complexity, Trialability, and Observability\u003c/strong\u003e\u0026mdash; are especially important for understanding the acceptance of healthcare providers and organizations to biosimilars. Analyzing each factor provides insights into the viewpoints, attitudes, and challenges influencing the adoption of biosimilars in healthcare environments (Gledson, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Qutaishat et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eRelative Advantage (RA)\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eRelative Advantage (RA), an essential factor of technology adoption, denotes the perceived benefits of new technologies in comparison to existing alternatives(Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Cupido \u0026amp; Jokonya, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Ninčević Pa\u0026scaron;alić \u0026amp; Ćuku\u0026scaron;ić, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Qatawneh, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Rehman et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Zhu et al., \u003cspan class=\"CitationRef\"\u003e2006\u003c/span\u003e). Relative advantage is defined as \u0026ldquo;the degree to which an innovation is perceived as being better than the idea it supersedes\u0026rdquo;(Everett M. Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e, p. 229). Relative Advantage (RA) is acknowledged in literature as a promoter for technological adoption, frequently associated with improved performance, operational efficiency, and cost-effectiveness. In supply chain contexts, blockchain technology\u0026apos;s ability to enhance transparency is a notable advantage that fosters trust and visibility across supply networks (Francisco \u0026amp; Swanson, \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e; Kamble et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eBiosimilars in healthcare have considerable relevance by offering a cost-effective substitute for expensive biologics while preserving therapeutic equivalence. This affordability improves patient accessibility, especially in cost-sensitive markets and price-sensitive healthcare systems addressing chronic conditions like rheumatoid arthritis and cancer. Recent studies indicate that biosimilars can decrease healthcare costs by around 20\u0026ndash;30%, a significant advantage for healthcare providers working under limited resources (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Gerard Quinn, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). The presence of biosimilars in the market enhances competitiveness, leading to decreased costs for original biologics and further solidifying the perceived advantages of employing biosimilars (Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Priyarega \u0026amp; Natarajan, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003ea; Raymond K. Cross et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eBiosimilars enhance healthcare equity by broadening access to biologic medicines in areas where the exorbitant cost of reference biologics restricts availability. Research on emerging markets highlights the revolutionary capacity of biosimilars in enhancing the accessibility of innovative medicines to a wider patient population (Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Shaina Shah \u0026amp; Pranav Patel, 2022). Consequently, regulatory approval for biosimilars aligns with healthcare organizations\u0026apos; objectives to enhance treatment cost and accessibility, particularly in contexts where biologics have traditionally been less accessible. Therefore, companies\u0026rsquo; conscious of these benefits should be compelled to adopt biosimilars.\u003c/p\u003e\n \u003cp\u003eThis research describes relative advantages as the benefits derived from developing biosimilars, proven by improved performance, operational efficiency, and/or cost-effectiveness.\u003c/p\u003e\n \u003cp\u003eBased on that, this research proposes the following:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP4: Adopting biosimilars production line provides notable relative advantage to Jordanian manufacturers that is easy to quantify.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eComplexity\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eComplexity, a key factor of the DOI theory, denotes the perceived challenges linked to understanding, executing, and integrating new technologies (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Nam et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Prasad Agrawal, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Rehman et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). Complexity is \u0026ldquo;\u003cem\u003ethe degree to which an innovation is perceived as relatively difficult to understand and use\u003c/em\u003e\u0026rdquo; (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e, p. 257).\u003c/p\u003e\n \u003cp\u003eThe literature on technology adoption has extensively examined complexity, indicating that advanced technological systems often require significant technical expertise (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Hnoosh \u0026amp; Courmier, \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e), comprehensive education for healthcare professionals (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Shaina Shah \u0026amp; Pranav Patel, 2022), and considerable organizational resources for successful integration (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e; Prasad Agrawal, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003eIn several businesses, particularly those necessitating high precision and regulatory adherence, complexity often constitutes a substantial obstacle to adoption(Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e; Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e). Research on technology adoption indicate that complex technologies necessitate comprehensive training, elevated technical proficiency, and increased organizational resources, potentially resulting in lowered adoption rates (Zhu et al., \u003cspan class=\"CitationRef\"\u003e2006\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThe complexity of integrating biosimilars into healthcare is particularly evident due to their advanced production methods and strict regulations. Biosimilars need rigorous quality controls to ensure safety and efficacy, hence delaying their production and market entry. These constraints can lead to increased production expenses, hindering market penetration (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e). Moreover, studies by Medlinskiene et al. (\u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e) and Raymond K. Cross et al. (\u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e) underscore the significance of accurate molecular replication and thorough clinical testing, both of which add further regulatory and industrial complexity to the development of biosimilars.\u003c/p\u003e\n \u003cp\u003eRegulatory regulations required comprehensive comparability studies and post-marketing surveillance for biosimilars to ensure therapeutic equivalence with originator biologics, therefore increasing their complexity. Compliance regulations provide significant challenges for firms in underdeveloped nations, since resource constraints impede market access (Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Priyarega \u0026amp; Natarajan, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003eb). The successful integration of biosimilars into healthcare necessitates comprehensive training for physicians and education for patients, especially in addressing misconceptions like the nocebo effect, which may influence patient acceptability (Gerard Quinn, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eBiosimilars are inherently more complex than other pharmaceutical treatments due to the intricate technologies involved, requiring lengthy testing and thorough comparison studies as demanded by regulatory agencies. Therefore, companies may exhibit resistance in adopting this technology. The complexity in this research is operationalized as the perceived difficulty associated with understanding, implementing, and integrating biosimilars.\u003c/p\u003e\n \u003cp\u003eAccordingly, this research has the following proposition:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP5: The perceived complexity in the production and quality control of biosimilars acts as a barrier to adoption in less technologically advanced organizations.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eCompatibility\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eCompatibility in technology adoption indicates the extent to which a new technology fits with an organization\u0026rsquo;s existing values, practices, systems, and infrastructure. Compatibility is \u0026ldquo;\u003cem\u003ethe degree to which an innovation is perceived as consistent with the existing values, past experience, and needs of potential adopters\u003c/em\u003e\u0026rdquo; (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e, p. 240). High compatibility frequently facilitates adoption by reducing the need for substantial modifications to existing processes (Tornatzky \u0026amp; Fleischer, (1990), (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e); (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e)). Studies across several industries demonstrate that technologies aligned with current organizational norms and procedures see greater adoption rates (Hasan Emon \u0026amp; Hoque Nahid, 2023; Zhong \u0026amp; Moon, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). The adoption of Industry 4.0 technologies in the industrial sector has been significantly influenced by their compatibility with existing processes and organizational culture (Zhong \u0026amp; Moon, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). Studies on the adoption of healthcare technology demonstrate that congruence with established procedures and organizational culture is essential for successful integration (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e)\u003c/p\u003e\n \u003cp\u003eIn the context of biosimilars, compatibility denotes adherence to prevailing healthcare practices, clinical standards, and the anticipations of healthcare practitioners. Biosimilars that can be seamlessly integrated into treatment regimens without necessitating substantial modifications are more likely to be embraced by healthcare professionals and patients (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e). Compatibility necessitates educational activities; healthcare professionals must be informed and adept in biosimilar medicines to effectively integrate them into medical environments (Gerard Quinn, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e). This research defines compatibility to the extent to which biosimilars fit with an organization\u0026apos;s established values, practices, systems, and infrastructure. Therefore, for this purpose, the following proposition is developed for this research:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP6: The compatibility of manufacturing biosimilars with the existing values, practices, systems, and infrastructure in Jordanian pharmaceuticals represents a challenge to the adoption process.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eTrialability\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eTrialability, a critical factor influencing technology adoption, which measures how easily an invention may be tried out or evaluated before being fully implemented (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e; Salah \u0026amp; Ayyash, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). Everett M. Rogers (\u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e) formally defined trialability as \u0026ldquo;\u003cem\u003ethe degree to which an innovation may be experimented with on a limited basis\u003c/em\u003e\u0026rdquo;. This factor is recognized in the literature as an adoption facilitator, since it allows companies to assess the risks, benefits, and operational consequences of a new technology prior to its complete integration (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e, p. 258). Technologies characterized by high trialability are more open to acceptance, since they facilitate education and adaptation, thereby reducing the uncertainties linked to adoption (Afshari-Mofrad \u0026amp; Salim, \u003cspan class=\"CitationRef\"\u003e2020\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eIn healthcare, trialability is essential due to the substantial risks associated with patient safety and treatment efficacy. Before the extensive implementation of novel treatments or technology, healthcare providers can evaluate outcomes and tackle obstacles via smaller-scale studies. The deployment of electronic health records (EHRs) generally involved incremental introductions or pilot programs to aid staff acclimatization and methodically address technological issues (Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Shaina Shah \u0026amp; Pranav Patel, 2022). Innovative diagnostic procedures and medical devices are frequently assessed in controlled environments or specific patient cohorts to gather data on their reliability, usability, and efficacy before broad deployment (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Saeed et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eIn the field of biosimilars, trialability is crucial for mitigating skepticism among healthcare professionals and patients. Biosimilars, unlike original biologics, can be evaluated in transitional patient populations, providing an opportunity to demonstrate therapeutic equivalence and safety. Research indicates that healthcare professionals are more likely to support the broader implementation of biosimilars in treatment protocols when provided with clinical evidence about their safety and efficacy (IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Raymond K. Cross et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e). This stepwise model for biosimilar introduction allows stakeholders to recognize issues related to immunogenicity, side effects, and patient acceptability. This project introduces tribality by enabling healthcare practitioners and patients to trial or evaluate biosimilars before full deployment.\u003c/p\u003e\n \u003cp\u003eAccordingly, this research has the following proposition:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP7: The ease and affordability of trialability of biosimilars in Jordan encourages Jordanian pharmaceuticals companies to adopt such new manufacturing line.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003e\u003cem\u003eObservability\u003c/em\u003e\u003c/p\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eObservability, another critical factor influencing technology adoption, refers to the degree to which the results and benefits of an innovation are visible to others (Amini \u0026amp; Bakri, \u003cspan class=\"CitationRef\"\u003e2015\u003c/span\u003e; Gledson, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Greenhalg et al., 2004; Salah \u0026amp; Ayyash, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). Everett M. Rogers (\u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e) defined observability as \u0026ldquo;\u003cem\u003ethe degree to which the results of an innovation are visible to others\u003c/em\u003e\u0026rdquo;. Innovations with readily visible outcomes typically attain higher adoption rates, since their benefits can be clearly shown and communicated to potential adopters (Everett M.Rogers, \u003cspan class=\"CitationRef\"\u003e2003\u003c/span\u003e, p.258). Literature constantly emphasizes observability as a critical aspect in technology dissemination, positing that the visibility of concrete outcomes and success narratives reduces ambiguity and bolsters adoption confidence (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eIn healthcare, observability profoundly influences the acceptance and dissemination of novel concepts within the sector. Exhibiting the effectiveness of novel technology or therapy, such as improved patient outcomes or cost reductions, motivates stakeholders to embrace the innovation. The adoption of telemedicine surged significantly as a result of the COVID-19 pandemic\u0026apos;s clear enhancements in healthcare delivery. Research indicates that the demonstration of concrete benefits, including decreased hospitalizations and enhanced patient satisfaction, promoted the extensive use of telemedicine services (Medlinskiene et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Valencia-Arias et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eIn the realm of biosimilars, observability is essential for alleviating mistrust among healthcare professionals and patients. The demonstrable impact of biosimilars in reducing treatment costs, improving access to biologics, and maintaining therapeutic equivalence with original medications is a significant factor facilitating their acceptance.Healthcare systems that have adopted biosimilars frequently report quantifiable cost reductions of 20\u0026ndash;30% (2023 U.S. Generic and Biosimilar Savings Report: Biosimilars Deliver on Their Promise, 2023; \u0026ldquo;Biosimilars of Infliximab,\u0026rdquo; 2020; Alawneh et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Fda et al., 2015; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Kurki et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Priyarega \u0026amp; Natarajan, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003ea; Scott Morton et al., \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e; Victoria Johnson, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). The introduction of biosimilars in the market has demonstrated a reduction in the costs of original biologics, resulting in improved affordability within healthcare systems and highlighting the competitive pricing benefits of biosimilars (2023 U.S. Generic and Biosimilar Savings Report: Biosimilars Deliver on Their Promise, 2023; Gasteiger \u0026amp; Petrie, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Hnoosh \u0026amp; Courmier, \u003cspan class=\"CitationRef\"\u003e2018\u003c/span\u003e; IQVIA, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; LUPIN, \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Victoria Johnson, \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). This research operationalizes observability to the extent to which the outcomes and advantages of biosimilars are visible to key stakeholders, including healthcare providers, patients, and pharmaceutical companies.\u003c/p\u003e\n \u003cp\u003eBased on that, this research proposes the following:\u003c/p\u003e\n \u003cp\u003e\u003cem\u003eP8: The observability of manufacturing and using biosimilars in Jordan\u0026rsquo;s limited and well-regulated market facilitates the organizational decision regarding biosimilar adoption.\u003c/em\u003e\u003c/p\u003e\n \u003c/div\u003e\n \u003c/div\u003e\n\u003c/div\u003e\n\u003cdiv id=\"Sec9\" class=\"Section2\"\u003e\n \u003ch2\u003e2.2 Application of TOE and DOI to Manufacturing Biosimilars\u003c/h2\u003e\n \u003cdiv class=\"BlockQuote\"\u003e\n \u003cp\u003eThe TOE and DOI frameworks offer complementary perspectives on biosimilar adoption. The TOE framework emphasizes the organizational and environmental contexts, while DOI focuses on the perceived attributes of innovation by internal staff and departments in greater detail. Applying both frameworks to biosimilars provides a holistic view of adoption barriers and drivers, addressing the unique challenges posed by biosimilar integration in healthcare, particularly in Jordan.\u003c/p\u003e\n \u003cp\u003ePrior Applications of TOE and DOI in Healthcare\u003c/p\u003e\n \u003c/div\u003e\n \u003cp\u003eThe Diffusion of Innovations (DOI) theory and the Technology-Organization-Environment (TOE) framework, either individually or in combination, have been widely used to study the adoption of healthcare technology, providing thorough insights into how innovations are assessed and incorporated (Al Teneiji et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e; Amini \u0026amp; Javid, n.d.; Bakshi et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e; Ghaleb et al., \u003cspan class=\"CitationRef\"\u003e2021\u003c/span\u003e; Macabasag et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e; Raymond K. Cross et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Rouidi et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e; Valencia-Arias et al., \u003cspan class=\"CitationRef\"\u003e2024\u003c/span\u003e). The introduction of biosimilars in the market has demonstrated a reduction in the costs of original biologics, resulting in improved affordability within healthcare systems and highlighting the competitive pricing benefits of biosimilars. For example, CRM technology adoption study used the TOE framework, emphasizing how organizational external factors influence adoption procedures (Cruz-Jesus et al., \u003cspan class=\"CitationRef\"\u003e2019\u003c/span\u003e). Furthermore, Implementation of Human-Computer Interaction (HCI) system in healthcare highlighted the importance of the TOE framework to enhance service delivery and usability (Mehta \u0026amp; Chaudhary, \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThe DOI theory enhances the TOE framework by examining the dissemination of innovations in organizations, emphasizing aspects such as relative benefit, compatibility, complexity, trialability, and observability. Employing DOI, Bakshi et al. (2021) examined the influence of robots\u0026rsquo; integration in healthcare on stakeholder acceptability and decision-making (Bakshi et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e). Rouidi et al. (\u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e) utilized the Diffusion of Innovations (DOI) theory in conjunction with other models to investigate health professionals\u0026apos; acceptance of telemedicine, revealing that adoption is influenced by communication routes and perceived benefits (Rouidi et al., \u003cspan class=\"CitationRef\"\u003e2022\u003c/span\u003e). Macabasag et al. (2022) emphasized the significance of DOI in comprehending the obstacles and enablers in the implementation of electronic medical records by illustrating the relationship between technical design and user experience (Macabasag et al., \u003cspan class=\"CitationRef\"\u003e2023\u003c/span\u003e).\u003c/p\u003e\n \u003cp\u003eThe TOE framework and DOI theory, when integrated, provide efficient methods for examining the adoption of healthcare technologies by considering \u003cstrong\u003emacro-level factors\u003c/strong\u003e (including technological, organizational, and environmental factors) and \u003cstrong\u003emicro-level factors\u003c/strong\u003e (such as relative advantage, complexity, compatibility, trialability and observability.. The TOE (Technology-Organization-Environment) framework is particularly useful in this research because Jordan is a developing country and not a technology producer. Therefore, it is essential to assess whether the technology required for biosimilar manufacturing is available or accessible. Additionally, despite having a well-regulated pharmaceutical industry, Jordan\u0026apos;s pharmaceutical manufacturing facilities are relatively new when compared to those in developed countries. The \u003cstrong\u003eTOE framework\u003c/strong\u003e enables an analysis of the technological and regulatory infrastructure that might either facilitate or hinder the adoption of biosimilar. While the \u003cstrong\u003eDiffusion of Innovations (DOI) framework\u003c/strong\u003e fits well with the research focus because one of the key questions is about the strategies and policies that can ensure the successful adoption of biosimilars in Jordan. To answer this, it is important to look at how prepared pharmaceutical companies are internally and what drives their readiness to adopt such innovations. By applying the DOI framework, we can gain insights into what has worked and what can be improved, offering recommendations that can be applied more broadly.\u003c/p\u003e\n \u003cp\u003eThe adoption of biosimilars is influenced by a combination of technological advancements, organizational readiness, and environmental factors. By examining these through the TOE framework, this research provides a comprehensive understanding of the key drivers behind biosimilar market growth, particularly in developing countries where cost considerations and regulatory support are critical.\u003c/p\u003e\n \u003cp\u003eInsert Figure 1 about here.\u0026nbsp;\u003c/p\u003e\n\u003c/div\u003e"},{"header":"3. Methodology","content":"\u003cdiv id=\"Sec11\" class=\"Section2\"\u003e \u003ch2\u003e3.1 Research design\u003c/h2\u003e \u003cp\u003eThis research uses a qualitative research methodology to investigate the factors influencing the adoption of biosimilars in Jordanian pharmaceutical companies. Qualitative research is particularly suitable when the objective is to comprehend underlying motivations and contextual factors (Mishra \u0026amp; Alok, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2017\u003c/span\u003e).\u003c/p\u003e \u003cp\u003eThe research employs exploratory design and uses semi-structured interviews to gather in-depth information from regulatory authorities and business executives who are well-experienced with biosimilars (directly or not directly) during the last 5 years (see appendix A). Mishra and Alok (\u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2017\u003c/span\u003e) assert that exploratory research is suitable for comprehending issues that are not yet distinctly characterized or where current explanations are inadequate. Semi-structured interviews provide flexibility, allowing the researcher to delve deeper into emergent themes while preserving consistency across interviews. A total of five interviews were conducted, focusing on those with high-level experience and decision-making authorities in the adoption of biosimilars. The interview questions were sent to respondents before to allow them to provide thoughtful and evidence-based responses. This design enables the exploration of contextual factors that are critical for understanding biosimilar adoption in the Jordanian pharmaceutical companies.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec12\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Sample design\u003c/h2\u003e \u003cp\u003eThe target population includes all the stakeholders that might have a say in biosimilar adoption. In this case, these are pharmaceutical companies and regulatory authorities. From this population, the researcher has selected a sample. The research utilized non-probability purposive sampling method, specifically expert sampling, which is suitable for qualitative research that seeks in-depth insights from individuals with specialized knowledge. This approach ensures the inclusion of key decision-makers and stakeholders with direct experience in biosimilar-related strategies and policies (Mishra \u0026amp; Alok, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2017\u003c/span\u003e). A sample of five high-level managers from Jordan\u0026rsquo;s pharmaceutical and regulatory sectors, the selection of these individuals was based on their direct participation in biosimilar adoption decision-making, which guaranteed the capture of rich, contextually relevant data. These participants include Tender manager, Vice President, Associate Director, and Marketing Director from three major pharmaceutical companies manufacturing Biosimilars and Manager Director of the Jordan Food and Drug Administration (JFDA).\u003c/p\u003e \u003cp\u003eAlthough this sample is not representative of all stakeholders and cannot be generalized to this sample is suitable for exploratory research even if it is not representative of all stakeholders and cannot be generalized for the whole industry. The individuals selected are excellent resources to understand the main barriers, drivers, and decision-making procedures in this setting since they have extensive knowledge and direct experience with biosimilar adoption in Jordan.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec13\" class=\"Section2\"\u003e \u003ch2\u003e3.2 Data Collection\u003c/h2\u003e \u003cp\u003eData was collected through semi-structured interviews which lasted approximately 60 minutes each. An interview guide was developed based on the research\u0026rsquo;s objectives, ensuring consistency across interviews. With the participants' permission, each interview was audio recorded, and the verbatim transcriptions were then analyzed. The interviews were conducted mainly in Arabic, keeping the questioning and the medical terms in English. First the transcriptions were done in Arabic and then translated into English for analysis. A professional translator was recruited for this purpose to ensure correctness of translation.\u003c/p\u003e \u003cp\u003eTwo university professors examined the interview questions to make sure they were understandable, pertinent, and in line with the research's goals. Additionally, Member verification, in which participants examined their transcripts to verify the correctness of their answers, was used to guarantee the findings' reliability (Mishra \u0026amp; Alok, \u003cspan citationid=\"CR36\" class=\"CitationRef\"\u003e2017\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec14\" class=\"Section2\"\u003e \u003ch2\u003e3.3 Data Analysis\u003c/h2\u003e \u003cp\u003eData analysis follows a thematic approach, allowing for systematic identification of patterns and themes across the interview data. Each interview transcript analyzed to extract key themes related to biosimilar adoption, drawing directly from participant responses to ensure authenticity. Thematic analysis is a popular method for examining qualitative data that involves finding, studying, and summarizing recurrent themes or patterns in the dataset. The ability to arrange and analyze vast amounts of textual material while keeping a close relationship to the original context makes it especially useful in systematic reviews and primary qualitative research (Thomas \u0026amp; Harden, \u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e2008\u003c/span\u003e). This process involves coding and categorizing data, identifying overarching themes that reflect the research's research questions. Direct participant quotes is integrated into the analysis to support thematic findings, offering depth and grounding to the conclusions. This approach is particularly effective for exploratory studies, as it provides a structured yet flexible means of capturing the nuanced perspectives of participants, ultimately yielding insights that are both comprehensive and contextually relevant (Thomas \u0026amp; Harden, \u003cspan citationid=\"CR57\" class=\"CitationRef\"\u003e2008\u003c/span\u003e).\u003c/p\u003e \u003c/div\u003e"},{"header":"4. Research Findings","content":"\u003cp\u003eThis section presents a thematic analysis of in-depth interviews conducted with key stakeholders in the Jordanian pharmaceutical sector.\u003c/p\u003e\n\u003ch2 id=\"_Toc198381831\"\u003e\u003cstrong\u003e4.1 Technology-Organization-Environment (TOE) Framework Key Findings\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003e\u003cstrong\u003eA.\u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eTechnological context\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme A.1 Limited Internal Technological Capabilities\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe findings indicate that Jordan lacks internal technology for producing biosimilars. In addition, Jordanian pharmaceutical companies do not have the know how to develop and produce biosimilars. Only a few companies appear capable of investing in the required technologies. Therefore, there was an theme of answers indicating that outsourcing manufacturing might be a sound resolution for Jordanian pharmaceutical companies.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Associate Director underlined this barrier by saying: \"\u003cem\u003ethe evaluation was \"very low\" as most companies import the biosimilar and only fill it. From my experience, there are contacts for a partial contact process in some countries, so it is difficult to find a way to manufacture it\u003c/em\u003e\".\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme A.2 Challenges in Technology Transfer and Access to External Technologies\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eWhile partnerships are theoretically possible, the findings emphasize that access to technology is not easy. The interviewees had a perception that the cost to acquire the technology to produce biosimilars in Jordan is beyond the capabilities of Jordanian companies.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor example, the Marketing Director said: \"\u003cem\u003ebiosimilar technology is very expensive for any Jordanian company to aspire to develop it, as the technology costs millions and manufacturing costs millions\u003c/em\u003e\".\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme A.3 Human Resource and Knowledge Gaps\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThere is a significant shortage of skilled personnel with biosimilar-specific experience in Jordan. Most firms depend on hiring expatriates or sending local staff abroad for training, which is costly and not scalable. The lack of in-house R\u0026amp;D capacity further limits technological self-sufficiency.\u003c/p\u003e\n\u003cp\u003eTherefore, it can be concluded that the technological barrier is a main barrier in adopting biosimilars in developing countries. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eB.\u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eOrganizational context\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme B.1 Inconsistent Management Commitment and Organizational Structure\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSupport for biosimilar adoption varies across companies. Some firms demonstrate high-level management support and have structured units or project management offices (PMOs) to handle biosimilar projects. Others lack administrative clarity or a dedicated biosimilar team. Centralized decision-making is common, especially for tender-driven markets. As a vice president mentioned, “Most biosimilar product decisions are made by senior management because tenders are usually monitored and managed from the highest managerial level.” Indicating that there is an agreement that the firm’s characteristics, such as structure, management, and number of employees are not a barrier towards manufacturing biosimilars in developing countries. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme B.2 Limited Financial and Organizational Resources\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eEven when the interest exists, the high capital and operational costs deter investment. Slack resources such as underutilized personnel and departments could support biosimilar initiatives, but only within firms with proper planning. \u0026nbsp;As Associate Director stated: “\u003cem\u003eit is necessary to bring in specialized experts and it can rely upon internally, but it is better to rely on experts coming from abroad\u003c/em\u003e.”\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme B.3 Communication and Cross-Functional Coordination\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the research, communication channels are available in JPCs and top companies in Jordan has Project Management Office, which help in communication coordination. For example, the Marketing Director stated, “\u003cem\u003ethe company follows a PMO (Project Management Office) that coordinates communication with clear responsibilities and clear communication process\u003c/em\u003e.” However, communication is lacking in many organizations. Informal structures dominate, leading to loss of information and misalignment. Formalizing cross-departmental collaboration is seen as critical to biosimilar development, particularly for aligning medical, regulatory, and marketing strategies.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme B.4\u0026nbsp;\u003c/em\u003e\u003cem\u003eStrategic Agility and Innovation Orientation\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAgile decision-making and innovation were frequently ranked as critical by interviewees. Companies that can rapidly respond to changing market and regulatory conditions are better positioned to invest in biosimilars. As the marketing director explained, “\u003cem\u003eAgile decision making is the most important, followed by innovation and then resource allocation\u003c/em\u003e.”\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eC.\u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eEnvironmental context\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme C.1 Regulatory Environment\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eThe Jordan Food and Drug Administration (JFDA) has adopted rigorous regulatory frameworks modeled after international standards. This promotes trust in Jordanian products but creates complex and lengthy approval processes. Clearer biosimilar-specific regulations are needed to facilitate local production. “JFDA is based on American and European procedures… there is a need to stand on the requirements for a Jordanian company to manufacture biosimilars,” stated a tender manager.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme C.2 Market and Competitive Pressures\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePatent expirations, rising healthcare costs, and international competition (especially from India and China) are driving interest in biosimilars. However, the small size of the Jordanian market limits the commercial viability of large-scale investment. Most companies aim to penetrate Gulf markets where demand is higher. A marketing director observed, \u003cem\u003e“If companies enter this field, the trend will be towards the Saudi market.”\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme C.3 Societal Trust and Market Acceptance\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003ePublic and physician trust in locally produced biosimilars remains low but is improving. Government tenders and successful treatment outcomes are key to shifting perceptions. Ensuring product safety and building reputation are essential.\u003cem\u003e\u0026nbsp;“Now, recently, there is more confidence in local manufacturing at the level of regular medicines,”\u0026nbsp;\u003c/em\u003enoted the tender manager.\u003c/p\u003e\n\u003ch2 id=\"_Toc198381832\"\u003e\u003cstrong\u003e4.2\u0026nbsp;Diffusion of Innovation (DOI) Theory\u0026nbsp;\u003c/strong\u003e\u003cstrong\u003eKey Findings\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003e\u003cem\u003eTheme D Limited Perceived Relative Advantage\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAccording to the literature, biosimilars have a relative advantage over biologics as their adoption leads to lower treatment bills. However, most interviewees were cautious about the relative advantage of biosimilars over biologics. Adoption is seen more as a cost-saving measure than an innovation strategy. The market-driven nature of biosimilar demand further weakens their perceived strategic value. “\u003cem\u003eIt cannot be said that it has a relative advantage… each type has its own market\u003c/em\u003e,” explained a tender manager. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme E Compatibility with Existing Systems\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eJPCs have good competencies that are compatible with biosimilars production, but it depends on how to utilize them. Existing systems in Jordanian firms are largely designed for generic drug production. Transitioning to biosimilars would require major infrastructural and procedural changes, posing compatibility challenges. The Associate Director highlighted, “\u003cem\u003eRegarding infrastructure, certainly not, but values yes\u003c/em\u003e.” The JFDA Director Manager stated, “\u003cem\u003ebiosimilars production aligns with JPC’s existing values, practices, systems, and infrastructure\u003c/em\u003e.”\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eBiosimilar production is still considered complex due to the precision required in manufacturing and regulatory compliance. This complexity discourages investment, especially from firms without prior biotechnological experience. “\u003cem\u003eThis issue is a complex procedure, not a difficulty in manufacturing or development, but rather a difficulty in the infrastructure\u003c/em\u003e,” stated the marketing director.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme F High Complexity\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBiosimilars manufacturing is still considered complex due to the precision required in manufacturing, regulatory compliance, and needed infrastructure. The JFDA Director Manager stated, “\u003cem\u003ethe unavailability of infrastructure is the main issue\u003c/em\u003e.” The Marketing Director confirmed by saying: “\u003cem\u003ethis issue is a complex procedure, not a difficulty in manufacturing or development, but rather a difficulty in the infrastructure\u003c/em\u003e.”\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme G Low Trialability\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOpportunities to pilot biosimilar production are minimal due to the absence of specialized labs and funding. Trialability could accelerate adoption but is currently underdeveloped. The Marketing Director stated, “\u003cem\u003eJPCs have their own R\u0026amp;D departments, but there is no specialized lab or any lab to test biosimilars\u003c/em\u003e”. Furthermore, The Associate Director said: “\u003cem\u003eif there is a test, adoption will be faster\u003c/em\u003e.”\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eTheme H Moderate Observability\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCost effectiveness and patient outcomes are the main observed benefits when products are included in tenders. However, more systematic tracking of outcomes and cost-savings is needed. The JFDA Director Manager said: “\u003cem\u003ethe Jordanian biosimilar product will certainly be cheaper than the imported one and will save the treasury, especially with regard to tenders\u003c/em\u003e.”\u003c/p\u003e\n\u003cp\u003eTable 1. presents a consolidated summary of how the study's research propositions align with the empirical evidence drawn from the thematic analysis. Each proposition—grounded in the TOE and DOI frameworks—is evaluated in terms of the level of support it received through interviews with stakeholders in the Jordanian pharmaceutical sector.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eInsert Table 1 about here.\u0026nbsp;\u003c/p\u003e\n\u003ch2 id=\"_Toc198381833\"\u003e\u003cstrong\u003e4.3 Propositions Evaluation Based on Research Findings\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eTo assess the relevance and accuracy of the study’s conceptual framework, each of the eight research propositions developed under the Technology-Organization-Environment (TOE) and Diffusion of Innovation (DOI) frameworks was evaluated against the themes identified through qualitative analysis. Table 2. below presents a proposition-by-proposition assessment, indicating the level of empirical support and summarizing the key justifications drawn from interview data. This evaluation not only validates or refines the theoretical assumptions but also provides context-specific insights into the factors shaping biosimilar adoption in Jordan.\u003c/p\u003e\n\u003cp\u003eInsert Table 2 about here.\u0026nbsp;\u003c/p\u003e"},{"header":"5. Discussion","content":"\u003ch2\u003e\u003cstrong\u003e5.2 Technology-Organization-Environment (TOE) framework\u003c/strong\u003e\u003c/h2\u003e\n\u003ch3 id=\"_Toc198381837\"\u003e\u003cstrong\u003e5.2.1. Technological Factors\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eFor the Internal Technologies\u003cstrong\u003e,\u0026nbsp;\u003c/strong\u003ethe research demonstrates that Jordanian Pharmaceutical Companies prefer secondary packaging over biosimilar production. In contrast to international competitors, Jordan lacks the necessary technological know-how and infrastructure, which is consistent with the literature showing that adoption is hindered by technical barriers (Moorkens et al., 2017). Additionally, the literature highlights how internal technology capabilities aid in the adoption of innovations (Cruz-Jesus et al., 2019) and the limited internal technological capabilities can hinder the adoption of complex technologies (Al Teneiji et al., 2024)\u003cstrong\u003e.\u0026nbsp;\u003c/strong\u003eFor the External Technologies\u003cstrong\u003e,\u0026nbsp;\u003c/strong\u003ethe research shows that Jordanian pharmaceutical companies are forced to rely on outside partnerships since the cost of obtaining biosimilar manufacturing technologies is too high. This goes opposite to global trends that concentrate more on local production in emerging economies in an effort to lower imports (Leonard et al., 2019). The literature supports that external technology access is a critical factor in determining the adoption of biosimilars, especially in underdeveloped nations (Afshari-Mofrad \u0026amp; Salim, 2020).\u003c/p\u003e\n\u003ch3 id=\"_Toc198381838\"\u003e\u003cstrong\u003e5.2.2 Organizational Factors\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eFor Firm’s Characteristics\u003cstrong\u003e,\u0026nbsp;\u003c/strong\u003ethe research implies that organizational structure and firm size do not have a direct impact on the adoption of biosimilars. But investing in biosimilars is more common among pharmaceutical companies with established management systems. This is supported by literature, which highlights how companies with agile, yet hierarchical decision-making structures make it easier for new ideas to be adopted (Amini \u0026amp; Bakri, 2015; Zhu et al., 2006). For Resources\u003cstrong\u003e,\u003c/strong\u003e according to the research, two of the biggest challenges are a lack of specialized human resources and financial limitations. Even while some companies are interested, they are unable to allocate the required capital for the manufacturing of biosimilars due to considerable financial constraints. This is corroborated by the literature showing that significant R\u0026amp;D and workforce training expenditures are necessary for the successful adoption of biosimilars (Cruz-Jesus et al., 2019; Medlinskiene et al., 2021). For Communication Channels, the research emphasized that both formal and informal communication channels are essential for the acceptance of biosimilars. Nevertheless, research shows that interdepartmental communication is still challenging and often results in the loss of important information because of disorganized and unstructured procedures. The implementation of biosimilars might require a more specialized and organized approach, even though a Project Management Office structure is already in place to facilitate communication. According to the key stakeholders, a specialized biosimilar division or department would enhance coordination by ensuring that all teams—R\u0026amp;D, regulatory affairs, and marketing—work under a same plan (Al Teneiji et al., 2024; Salah \u0026amp; Ayyash, 2024).\u003c/p\u003e\n\u003ch3 id=\"_Toc198381839\"\u003e\u003cstrong\u003e5.2.3 Environmental Factors\u003c/strong\u003e\u003c/h3\u003e\n\u003cp\u003eFor Regulations, according to the research, Jordan's regulatory system is very supportive to the adoption of biosimilars, with specific guidelines that meet with international standards including EMA regulations. Stakeholders interviewed highlighted that the Jordan Food and Drug Administration (JFDA), which is renowned for its regulatory efficiency and clarity, has created one of the MENA region's most efficient and transparent regulatory regimes. This is consistent with literature showing that a clear regulatory framework is essential for speeding up the introduction of biosimilars onto the market while upholding strict safety and effectiveness requirements (Afshari-Mofrad \u0026amp; Salim, 2020). For Competition, local adoption is further constrained by competition from China and India, which makes it difficult for Jordanian Pharmaceutical Companies to invest in the manufacturing of biosimilars. Because they provide biosimilars at far reduced prices. Literature supports this, indicating that competition from global players impacts pricing strategies and market penetration for biosimilars (Kurki et al., 2021). For Societal Attitudes, research reveals that initial skepticism towards biosimilars may be observed among healthcare professionals and patients, but confidence in local pharmaceutical companies points to a promising future. which is consistent with literature that indicates biosimilar adoption is encouraged by public confidence in local pharmaceutical companies (Alawneh et al., 2022). Additionally, once biosimilars are widely accessible, skepticism tends to decrease (Gasteiger \u0026amp; Petrie, 2022; IQVIA, 2023).\u003c/p\u003e\n\u003ch2 id=\"_Toc198381840\"\u003e\u003cstrong\u003e5.3 DOI Theory\u003c/strong\u003e\u003c/h2\u003e\n\u003cp\u003eFor Relative Advantage, the research shows that biosimilars are a more affordable option than biologics, which is consistent with research showing that cost reductions and increased accessibility are important factors in the uptake of biosimilars (Shaina Shah \u0026amp; Pranav Patel, 2022). Furthermore, financial gain, potential savings of 20–30%, is a major motivator for adoption, supporting international research highlighting the economic advantages of biosimilars (Ghaleb et al., 2021; Medlinskiene et al., 2021). For Complexity, the research shows that the creation of biosimilars is thought to be extremely complicated because of production and regulatory issues. This is supported by literature, which highlights the need for advanced infrastructure and knowledge due to the technical complexity of new technology (Afshari-Mofrad \u0026amp; Salim, 2020). For Compatibility, according to the research, the degree to which biosimilars fit with current production capacities, regulations, and healthcare practices determines how widely they are adopted by Jordanian pharmaceutical companies. The findings show that although Jordan's clinical and regulatory systems are favorable, local pharmaceutical companies have difficulties incorporating biosimilars into their current supply chains and production processes. For seamless integration into treatment regimens, healthcare personnel also need further training. Adoption may be slowed by the gap between present capabilities and the need for producing biosimilars unless companies make investments in workforce development and technological adaption (Afshari-Mofrad \u0026amp; Salim, 2020; IQVIA, 2023). For Trialability, the research shows that while biosimilars are subject to case studies prior to being included in government tenders, this only applies to biosimilars that already have FDA approval. Because the current facilities have been constructed for generic molecules and are not appropriate for biosimilars, Jordan lacks specializing laboratories for biosimilar trialability. This is corroborated by literature, which shows that one important consideration is the capacity to test novel treatments before their widespread adoption (Gerard Quinn, 2024). For Observability, according to the research, the adoption of biosimilars is encouraged by financial savings and favorable patient outcomes. Literature demonstrates that tangible advantages promote market adoption and government approval (IQVIA, 2023; Scott Morton et al., 2018).\u003c/p\u003e"},{"header":"6. Conclusion and implications","content":"\u003cp\u003eThis study presents a comprehensive examination of the factors influencing the adoption of biosimilars in Jordanian Pharmaceutical Companies by combining the Diffusion of Innovation (DOI) theory with the Technology-Organization-Environment (TOE) framework, this provides comprehensive understanding of both internal and external factors influencing the adoption of biosimilars.\u003c/p\u003e \u003cp\u003eFrom technological perspectives, the lack of internal technology abilities and limited access to external technologies, expertise and know-how are major barriers to biosimilars adoption. Currently, Jordanian pharmaceutical companies use secondary packaging over full-scale biosimilar production, due to complexity (internal factors) studied through the DOI theory which consider the biosimilar production a complex process due to unavailability of internal technologies, lack of experience and the know-how.\u003c/p\u003e \u003cp\u003eFrom organizational perspectives, firm\u0026rsquo;s characteristics are not a major factor for biosimilar production, although its reputation and size may facilitate the adoption, the management system and top management support remains the key factors relating to this, on the other hand, even the JPCs have good human resources, they lack biosimilar related experience, this shows a barrier for biosimilar adoption. Although the top management determines the economic benefits and the positive impact of biosimilar production on company\u0026rsquo;s market presence, JPCs prefer to use secondary packaging over full-scale biosimilar production, as the lack of infrastructure makes the company\u0026rsquo;s resources incompatible with biosimilars production resources, lack of expertise and specialized trial laboratory, make the relative advantage unclear for them. These internal factors (Relative Advantage, Compatibility and Trialability) studied through the DOI theory.\u003c/p\u003e \u003cp\u003eFrom organizational perspectives, although regulations in Jordan are very supportive to biosimilars\u0026rsquo; adoption, nonetheless, competition from Indian and Chinese companies form a threat for this large investment, in addition to expected initial societal attitudes of skepticism limit the observable benefits of biosimilars production in JPCs.\u003c/p\u003e \u003cdiv id=\"Sec26\" class=\"Section2\"\u003e \u003ch2\u003e6.1Theoretical Contribution\u003c/h2\u003e \u003cp\u003eThis study enhances the theoretical framework of biosimilar adoption by applying the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory to the pharmaceutical sector in a developing market. This research offers a fresh viewpoint on biosimilar adoption by applying established frameworks to Jordan, a country characterized by distinct legal and economic factors.\u003c/p\u003e \u003cp\u003eThe study contributes to the TOE framework by revealing the interaction of technological, organizational, and environmental factors in influencing biosimilar adoption. It emphasizes that although regulatory support is present, technological, and financial limitations surpass its benefits, making adoption complicated. In addition, the finding contribute to the TOE model by highlighting the significance of technological and financial accessibility in pharmaceutical contexts. The application of DOI theory to the adoption of biosimilars illustrates how factors like relative advantage, complexity, compatibility, trialability, and observability influence adoption options. Despite the clear relative advantage and cost-effectiveness, the perceived complexity of biosimilars continues to be a substantial barrier. This research indicates that DOI theory must consider the significant regulatory compliance associated with biosimilars, distinguishing them from other innovations.\u003c/p\u003e \u003cp\u003eFinally, this research contributes to the literature by offering empirical data that supports the integration of the TOE and DOI frameworks, illustrating their complimentary functions in understanding the adoption of complicated pharmacological innovations.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec27\" class=\"Section2\"\u003e \u003ch2\u003e6.2 Practical Implications\u003c/h2\u003e \u003cp\u003eThe findings of this research contain significant importance for stakeholders such as legislators, pharmaceutical companies, and healthcare professionals in Jordan and similar developing nations. The research highlights the necessity for authorities to establish enhanced financial incentives and infrastructure to promote local biosimilar production. Although regulatory systems comply with international standards, supplementary measures like subsidies, tax incentives, and investment in research and development can facilitate adoption. Establishing specialized biosimilar trial laboratories in Jordan could reduce reliance on international testing facilities and enhance trialability for local companies. Additionally, this research underscores the significance of partnerships between pharmaceutical companies and global biosimilar manufactures. Due to the substantial costs and technological barriers linked to biosimilar production, collaborating with multinational companies can enhance the know-how information exchange, increase technology accessibility, and minimize financial risks. Moreover, companies have to evaluate investing in specific training programs to cultivate internal knowledge and address the existing skills deficit in biosimilar production.\u003c/p\u003e \u003cp\u003eHealthcare professionals and organizations must contribute to enhancing biosimilar adoption by reducing skepticism and eliminating misconceptions. Educational programs aimed at healthcare providers and patients can foster trust in biosimilars and improve their acceptance. Training initiatives, workshops, and case studies emphasizing the efficacy and safety of biosimilars can enhance their observability and promote greater adoption.\u003c/p\u003e \u003c/div\u003e \u003cdiv id=\"Sec28\" class=\"Section2\"\u003e \u003ch2\u003e6.3 Limitations and Future Studies\u003c/h2\u003e \u003cp\u003e \u003cdiv class=\"BlockQuote\"\u003e \u003cp\u003eThe qualitative, cross-sectional design of the research makes it difficult to track long-term trends in the adoption of biosimilars. Further longitudinal research may provide more in-depth understanding of Jordan's changing market and regulatory conditions\u003c/p\u003e \u003cp\u003eFurthermore, the non-probability sample design and the sample size limits broad generalizations even though it is enough for qualitative analysis in exploratory studies. Future research may suggest alternative outcomes if the participant pool is expanded to include a wider variety of stakeholders, including legislators and medical professionals for example.\u003c/p\u003e \u003cp\u003eFinally, future research can focus on assessing the financial effects of adopting biosimilars, policy-oriented economic studies have to be carried out. According to healthcare research methodologies (Drummond, 2015), cost-benefit analysis (CBA) and economic modeling techniques can be utilized to evaluate pricing options, cost reductions, and financial feasibility.\u003c/p\u003e \u003c/div\u003e \u003c/p\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003eAll participants involved in this study were senior executives who voluntarily agreed to participate. Informed consent was obtained from all participants prior to the interviews. They were assured of the confidentiality and anonymity of their responses. No personally identifiable information was collected. The study protocol, including the consent process, was approved by the German Jordanian University.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eAfshari-Mofrad, M., \u0026amp; Salim, A. (2020). Iranian firms in biopharmaceutical value chain: Where to go now? 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Management Science, 52(10), 1557\u0026ndash;1576. https://doi.org/10.1287/mnsc.1050.0487\u003c/li\u003e\n\u003c/ol\u003e"},{"header":"Table","content":"\u003cp\u003eTable 1 is available in the Supplementary Files section\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":true,"highlight":"","institution":"German Jordanian University","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Adoption barriers, Biosimilars, Diffusion of Innovation (DOI), Healthcare innovation, Jordan, Pharmaceutical industry, Regulatory frameworks, Technology-Organization-Environment (TOE)","lastPublishedDoi":"10.21203/rs.3.rs-6899804/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6899804/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003eThis research explores the factors influencing the adoption of biosimilars by Jordanian pharmaceutical companies, employing the Technology-Organization-Environment (TOE) framework and the Diffusion of Innovation (DOI) theory. Using an exploratory qualitative design, semi-structured interviews were conducted with five key stakeholders, including senior executives from leading pharmaceutical firms and the Jordan Food and Drug Administration (JFDA). The findings confirm a consensus on the relative advantages of biosimilars\u0026mdash;such as improved affordability, access, and competitiveness. However, substantial barriers to adoption were also found. From the pharmaceutical companies\u0026rsquo; perspective, key challenges include high manufacturing costs, investment risks, and a lack of internal expertise, as current involvement is limited to secondary packaging. From the regulatory authority\u0026rsquo;s viewpoint, barriers include insufficient local infrastructure, limited biosimilar-specific testing labs, and skepticism from healthcare professionals and patients.\u003c/p\u003e \u003cp\u003eThe study provides theoretical contributions by extending the TOE and DOI frameworks to the biosimilar context in a developing market, highlighting unique organizational and environmental variables. Practically, this research contributes to decision makers in pharmaceutical companies, regulatory institutions, and suggests practical steps to enhance the adoption in biosimilars, contributing to long-term healthcare cost containment and innovation.\u003c/p\u003e","manuscriptTitle":"Understanding the factors influencing the adoption of biosimilars; an innovation theory perspective","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-24 12:20:31","doi":"10.21203/rs.3.rs-6899804/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"93d49b52-d63c-42e5-a430-4b50c635d8b8","owner":[],"postedDate":"June 24th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[{"id":50421925,"name":"Health Economics \u0026 Outcomes Research"},{"id":50421926,"name":"Clinical Pharmacology"},{"id":50421927,"name":"Health Policy"},{"id":50421928,"name":"Food Science \u0026 Technology"}],"tags":[],"updatedAt":"2025-06-24T12:20:31+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-24 12:20:31","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6899804","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6899804","identity":"rs-6899804","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}