FDA Issues Guidance on Bioequivalence Studies
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).
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.
Reference
- FDA, “Requirements for Submission of Bioequivalence Data; Final Rule.” Fed. Regist.74(11), 2849–2862 (Jan. 16, 2009).
Drug Shortages and Complying with FDA’s 21 CFR 211.110 Guidance
April 2nd 2025Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, and Rona LeBlanc-Rivera, PhD, principal consultant, Regulatory Affairs at Regulatory Compliance Associates, answer some questions about FDA’s January 2025 21 CFR 211.110 guidance document.
Mastering Antibody-Drug Conjugates
December 19th 2024In this episode, we explore BIOVECTRA’s capabilities in antibody-drug conjugate (ADC) manufacturing, from complex conjugation chemistry to synthesis of highly potent payloads. We’ll also showcase how BIOVECTRA’s extensive experience in complex chemistries and specialized small molecule manufacturing gives them a unique perspective, strengthening their approach to ADC production and ensuring clients receive custom solutions across all project stages.
AES Clean Technology Launches Next-Generation OSM Utility Solution for Cleanrooms at INTERPHEX 2025
April 2nd 2025Officially launched at INTERPHEX 2025, the Omni ASCENT is a next-generation off-site manufactured vertical utility solution that offers optimized cleanroom flexibility and efficiency.
