On June 29, 2015, FDA released 44 new and 4 revised product-specific bioequivalence recommendations for the development of generic drugs. FDA has now published a total of 1321 bioequivalence recommendations, listed by the active ingredient, on its website.
Under 21 CFR 320.24, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among the several in vivo and in vitro methods set forth in the regulation; FDA may require applicants to perform either or both type of methods to test the specific drug products depending on the purpose of the study, the analytical methods available, and the nature of the drug product.
In December of 2013, FDA published a Draft Guidance for the Industry entitled “Bioequivalence Studies with Pharmacokinetic Endpoints for Drugs Submitted Under an [Abbreviated New Drug Application] ANDA.” FDA intended this as a basic guidance to assist the generic pharmaceutical industry with identifying the most appropriate drug development methodology that generates the evidence needed to support ANDA approval. The bioequivalence recommendations on developing generic drug products that are therapeutically equivalent to specific reference listed drugs are FDA’s specific guidance to the industry.
Feedback on the 48 recommendations should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015.