FDA Issues Guidance on Bioequivalence Studies

May 12, 2011
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This month, FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications (ANDAs). The guidance is meant to clarify the requirements for the submission of bioequivalence data that were published in 2009 (1). Federal regulations require that all bioequivalence studies performed for a given agent be submitted as part of the ANDA, regardless of whether the study confirms that the product is equivalent to the reference listed drug (RLD).

FDA believes that review of both positive and negative data may be “important in our determination of whether a product is bioequivalent to the RLD and are relevant to our evaluation of generic products in general,” according to the guidance. “These data will increase our understanding of generic drug development and how changes in components and composition may affect formulation performance, as well as promote further development of science-based bioequivalence policies,” says the guidance.

The guidance consists of two sections. The first section clarifies what types of ANDAs must include all bioequivalence studies and specifies the necessary format for a summary report. The second section clarifies what the meaning of “the same product formulation” for immediate-release drug forms, extended-release drug products, semisolid dosage forms, and other complex dosage forms. This section also contains examples of slightly different formulations that would be considered the same product, and of other formulations that would be considered different.


1. FDA, “Requirements for Submission of Bioequivalence Data; Final Rule.” Fed. Regist. 74(11), 2849–2862 (Jan. 16, 2009).

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