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The main reason for concern relates to the uncertainty on whether, and when, two generics found to be bioequivalent to the same brand (reference) product are bioequivalent to each other, and the risk of a switch between generics resulting in clinically significant changes in plasma ASM concentrations. This article addresses these concerns by discussing the distinction between bioequivalence and statistical testing for significant difference, the importance of intra\u2010subject variability in interpreting bioequivalence studies, the stricter regulatory bioequivalence requirements applicable to narrow\u2010therapeutic\u2010index (NTI) drugs, and the extent by which currently available generic products of ASMs comply with such criteria. Data for 117 oral generic products of second\u2010generation ASMs approved in Europe by the centralized, mutual recognition or decentralized procedure were analyzed based on a review of publicly accessible regulatory assessment reports. The analysis showed that for 99% of generic products assessed (after exclusion of gabapentin products), the 90% confidence intervals (90% CIs) of geometric mean ratios (test\/reference) for AUC (area under the drug concentration vs time curve) were narrow and wholly contained within the acceptance interval (90%\u2013111%) applied to NTI drugs. Intra\u2010subject variability for AUC was &lt;10% for 53 (88%) of the 60 products for which this measure was reported. Many gabapentin generics showed broader, 90% CIs for bioequivalence estimates, and greater intra\u2010subject variability, compared with generics of other ASMs. When interpreted within the context of other available data, these results suggest that any risk of non\u2010bioequivalence between these individual generic products is small, and that switches across these products are not likely to result in clinically relevant changes in plasma drug exposure. The potential for variability in exposure when switching across generics is likely to be greatest for gabapentin.<\/jats:p>","DOI":"10.1111\/epi.16802","type":"journal-article","created":{"date-parts":[[2021,1,15]],"date-time":"2021-01-15T04:15:01Z","timestamp":1610684101000},"page":"285-302","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":19,"title":["Bioequivalence and switchability of generic antiseizure medications (ASMs): A re\u2010appraisal based on analysis of generic ASM products approved in Europe"],"prefix":"10.1111","volume":"62","author":[{"given":"Reem","family":"Odi","sequence":"first","affiliation":[{"name":"Faculty of Medicine Institute of Drug Research School of Pharmacy The Hebrew University of Jerusalem Jerusalem Israel"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Valentina","family":"Franco","sequence":"additional","affiliation":[{"name":"Division of Clinical and Experimental Pharmacology Department of Internal Medicine and Therapeutics University of Pavia Pavia Italy"},{"name":"IRCCS Mondino Foundation (member of the ERN EpiCARE) Pavia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0001-8703-223X","authenticated-orcid":false,"given":"Emilio","family":"Perucca","sequence":"additional","affiliation":[{"name":"Division of Clinical and Experimental Pharmacology Department of Internal Medicine and Therapeutics University of Pavia Pavia Italy"},{"name":"IRCCS Mondino Foundation (member of the ERN EpiCARE) Pavia Italy"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2046-4171","authenticated-orcid":false,"given":"Meir","family":"Bialer","sequence":"additional","affiliation":[{"name":"Faculty of Medicine Institute of Drug Research School of Pharmacy The Hebrew University of Jerusalem Jerusalem Israel"},{"name":"Affiliated with the David R. 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