FDA guidance: M9 biopharmaceutics classification system-based biowaivers

The US Food and Drug Administration has 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. 1

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.