BEBAC  Ing. Helmut Schütz


BCS-based Biowaivers

On 21 December 2017 the FDA’s Center for Drug Evaluation and Research (CDER) published the final Guidance for Industry

This guidance provides recommendations for sponsors of investigational new drug applications (INDs), and applicants who submit new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplements to these applications for immediate-release (IR) solid oral dosage forms, and who wish to request a waiver of an in vivo bioavailability (BA) and/or bioequivalence (BE) study requirement. These recommendations are intended to apply to waivers requested during the IND period and the NDA stage or for ANDAs, i.e., (1) subsequent in vivo BA or BE studies of formulations after the initial establishment of the in vivo BA of IR solid oral dosage forms during the IND period, and (2) in vivo BE studies of IR solid oral dosage forms in NDAs, ANDAs, and supplements to these applications.

Regulations at 21 CFR 320 address the requirements for BA and BE data for approval of NDAs, ANDAs, and supplemental applications. Provision for waivers of in vivo BA/BE studies (biowaivers) under certain conditions is provided at 21 CFR 320.22.This guidance finalizes the guidance for industry on Waiver of In Vivo Bioavailability and Bioequivalence Studies for Immediate-Release Solid Oral Dosage Forms Based on a Biopharmaceutics Classification System, published in May 2015, and explains when bio­waivers can be requested for IR solid oral dosage forms based on an approach termed the Biopharmaceutics Classification System (BCS). This guidance includes biowaiver extension to BCS class 3 drug products, and additional modifications, such as criteria for high permeability and high solubility.