FDA Announces Availability of a Final Guidance, M9 Biopharmaceutics Classification System-Based Biowaivers

Read more about the final ICH guidance titled M9 Biopharmaceutics Classification System-Based Biowaivers

FDA Announces Availability of a Final Guidance, M9 Biopharmaceutics Classification System-Based Biowaivers On May 12th, 2021, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled "M9 Biopharmaceutics Classification System-Based Biowaivers." This final guidance was prepared by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and provides recommendations on the biopharmaceutic classification of drug products and drug substances to inform whether a Biopharmaceutics Classification System (BCS)-based waiver of in vivo bioequivalence studies for drug products is appropriate. Two drug products containing the same drug substance or substances are considered bioequivalent if their bioavailabilities (rate and extent of drug absorption) after administration in the same molar dose lie within acceptable predefined limits. These limits are set to ensure comparable in vivo performance, i.e., similarity in terms of safety and efficacy. In in vivo bioequivalence studies, the pivotal pharmacokinetic parameters area under the concentration time curve (AUC) and the maximum concentration (Cmax) are generally used to assess the rate and extent of drug absorption. A BCS-based biowaiver approach reduces the need for in vivo bioequivalence studies through the determination that in vitro data regarding the aqueous solubility and intestinal permeability of the drug substance, as well as dissolution of the drug product, can justify an assumption of equivalence in in vivo performance. This 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 in this guidance. This guidance describes: (1) the BCS classification system for drug substances; (2) the criteria for eligibility of a drug product for a BCS-based biowaiver; (3) the necessary documentation for regulatory acceptance of a BCS-based biowaiver; (4) technical considerations for permeability assays; and (5) how to assess differences in excipients between drug products. Finalization of this guidance will help increase the consistent application of this biowaiver approach across agencies world-wide and reduce unnecessary in vitro and in vivo studies. The M9 Biopharmaceutics Classification System-Based Biowaivers final guidance is available at https://go.usa.gov/xHHuW. Please refer to this guidance for more details. The Office of Clinical Pharmacology (OCP) is pleased to offer the e-mail subscription service Clinical Pharmacology Corner. This is a free service from FDA to provide occasional updates from OCP regarding newly approved therapies, new regulatory and scholarly publications, upcoming events and other items of interest. Subscribe today at https://public.govdelivery.com/accounts/USFDA/subscriber/topics and select Clinical Pharmacology Corner under Drugs. We always welcome your thoughts regarding the format, content, and utility of this communication. Comments may be sent via email to ocp@fda.hhs.gov. This communication was prepared by the Office of Clinical Pharmacology, Office of Translational Sciences, CDER, FDA.

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