Drug Brand Switching: A Regulatory Perspective

Drug Brand Switching: A Regulatory Perspective | Authorea try { document.documentElement.classList.add('js'); } catch (e) { } var _gaq = _gaq || []; _gaq.push(['_setAccount', 'G-8VDV14Y67G']); _gaq.push(['_trackPageview']); (function() { var ga = document.createElement('script'); ga.type = 'text/javascript'; ga.async = true; ga.src = ('https:' == document.location.protocol ? 'https://ssl' : 'http://www') + '.google-analytics.com/ga.js'; var s = document.getElementsByTagName('script')[0]; s.parentNode.insertBefore(ga, s); })(); Skip to main content Preprints Collections Wiley Open Research IET Open Research Ecological Society of Japan All Collections About About Authorea FAQs Contact Us Quick Search anywhere Search for preprint articles, keywords, etc. Search Search ADVANCED SEARCH SCROLL This is a preprint and has not been peer reviewed. Data may be preliminary. 18 February 2026 V1 Latest version Share on Drug Brand Switching: A Regulatory Perspective Authors : Ping Siu Kee 0000-0003-2194-6543 [email protected] , Paul Chin KL 0000-0002-5470-5191 , Michael Tatley , Rhiannon Braund , Ruth Savage , Martin Kennedy A , and Simran Maggo DS 0000-0002-7779-5206 Authors Info & Affiliations https://doi.org/10.22541/au.177140889.99997579/v1 125 views 84 downloads Contents Abstract Supplementary Material Information & Authors Metrics & Citations View Options References Figures Tables Media Share Abstract The replacement of expensive medications marketed by companies that bore the cost of development and testing, by low-cost “generics” once patent protection ends, is a common step in the life cycle of most drugs. Although generics are required to meet strict bioequivalence standards, the introduction of first time and subsequent generics may lead to anxiety and increased reports of adverse effects or therapeutic failure. Whether these are real or imagined by those using them, can be challenging to assess. With the ongoing debate, this paper primarily explores how the regulatory framework governing generic drug approval may have contributed to this medical conundrum. In addition, we also offer a perspective on the potential role of pharmacogenetics within this setting. Supplementary Material File (pds-26-0141-file001.docx) Download 524.79 KB Information & Authors Information Version history V1 Version 1 18 February 2026 Copyright This work is licensed under a Non Exclusive No Reuse License. Keywords 80/125 rule bioequivalence brand to generic drug brand switching generic medicine generic substitution innovator medicine pharmacogenetics pharmacovigilance therapeutic equivalent Authors Affiliations Ping Siu Kee 0000-0003-2194-6543 [email protected] University of Otago Christchurch View all articles by this author Paul Chin KL 0000-0002-5470-5191 University of Otago Christchurch Department of Medicine View all articles by this author Michael Tatley New Zealand Pharmacovigilance Centre View all articles by this author Rhiannon Braund New Zealand Pharmacovigilance Centre View all articles by this author Ruth Savage University of Otago Christchurch View all articles by this author Martin Kennedy A University of Otago Christchurch View all articles by this author Simran Maggo DS 0000-0002-7779-5206 Shenandoah University View all articles by this author Metrics & Citations Metrics Article Usage 125 views 84 downloads .FvxKWukQNSOunydq8rnd { width: 100px; } Citations Download citation Ping Siu Kee, Paul Chin KL, Michael Tatley, et al. Drug Brand Switching: A Regulatory Perspective. Authorea . 18 February 2026. DOI: https://doi.org/10.22541/au.177140889.99997579/v1 If you have the appropriate software installed, you can download article citation data to the citation manager of your choice. Simply select your manager software from the list below and click Download. For more information or tips please see 'Downloading to a citation manager' in the Help menu . Format Please select one from the list RIS (ProCite, Reference Manager) EndNote BibTex Medlars RefWorks Direct import Tips for downloading citations document.getElementById('citMgrHelpLink').addEventListener('click', function() { popupHelp(this.href); return false; }); $(".js__slcInclude").on("change", function(e){ if ($(this).val() == 'refworks') $('#direct').prop("checked", false); $('#direct').prop("disabled", ($(this).val() == 'refworks')); }); View Options View options PDF View PDF Figures Tables Media Share Share Share article link Copy Link Copied! 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