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The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.
FDA published M9 Biopharmaceutics Classification System-Based Biowaivers on May 11, 2021 to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System (BCS)-based waiver of the in-vivo bioequivalence study requirement for drugs. The guidance was developed by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and supersedes FDA’s December 2017 guidance document, Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System.
According to FDA, if two drugs contain the same drug substance, they are bioequivalent if the rate and extent of drug absorption after administration in the same molar dose are within the acceptable predefined limits. Using a BCS-based biowaiver approach reduces the need for in-vivo studies to determine bioequivalence and may reduce costs and increase efficiency in generic drug development. This approach applies to immediate release, solid orally administered dosage forms or suspensions that deliver the drug to the systemic circulation. Fixed-dose combination products may be eligible if all active drug substances fulfill the criteria. Drugs with a narrow therapeutic index are not eligible for the BCS-based biowaiver.