Generics and the truth about bioequivalence
Acceptable variation margins, trust in the production chain, and impact on clinical practice
Grupo Bipp
3 min read
September 13, 2025
Sources
- European Medicines Agency (EMA). Guideline on the investigation of bioequivalence. 2010. U.S. Food and Drug Administration (FDA). Guidance for industry: bioequivalence studies with pharmacokinetic endpoints for drugs submitted under an ANDA. 2013.
- Agência Nacional de Vigilância Sanitária (Anvisa). Resolução RDC n.º 31, de 11 de agosto de 2010: guia para estudos de equivalência farmacêutica e bioequivalência.
- Davit BM, Nwakama PE, Buehler GJ, Conner DP, Haidar SH, Patel DT, et al. Comparing generic and innovator drugs: 12 years of FDA bioequivalence data. Ann Pharmacother. 2009;43(10):1583-97. doi:10.1345/aph.1M141
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Written by Grupo Bipp
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