FDA publishes guidance for industry: M9 Biopharmaceutics Classification System-Based Biowaivers On May 11, 2021, the FDA published the guidance for industry entitled "M9 Biopharmaceutics Classification System-Based Biowaivers," a draft of which was issued in October 2018. The guidance provides recommendations to support the biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in vivo bioequivalence study requirement for drug products. The BCS-based biowaiver approach is intended to reduce the need for in vivo studies to establish bioequivalence. This can help to reduce unnecessary costs and increase efficiency in generic drug development while continuing to meet the evidentiary standards for bioequivalence to the brand drug. Examples include comparison between products used during clinical development through commercialization, post-approval changes, and applications for generic drug products in accordance with regional regulations. The BCS-based biowaiver is only applicable to immediate release, solid orally administered dosage forms or suspensions designed to deliver the drug to the systemic circulation. Drug products having a narrow therapeutic index are excluded from consideration for a BCS-based biowaiver. Fixed-dose combination products are considered eligible for a BCS-based biowaiver in cases where all the active drug substances fulfill the criteria. To aid applicants, the FDA has also posted summary tables for ANDA submissions that contain BCS-based waiver requests pursuant to ICH Guideline M9: Biopharmaceutics Classification System-Based Biowaivers. This guidance was developed within the Expert Working Group (Multidisciplinary) of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and was recommended for adoption in November 2019. This guidance supersedes the December 2017 FDA guidance for industry "Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System." Additional resources: |
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