The Gradually Expanding Scope for Biowaivers of Oral Products: An Overview

The regulatory paradigm is relaxing gradually without compromising the safety, efficacy and the quality of the drug product and, most importantly, a perceptible scientific consensus is maturing towards the need of affordable medicines. The establishment of bioequivalence (BE) is no longer being considered to be accomplished only by in vivo studies in oral drug products. The potential use of in vitro dissolution testing in lieu of BE studies has now been regulatory adopted and is commonly referred to as “biowaiver”. Further, the advent of biopharmaceutics classification system (BCS) and in vitro-in vivo correlation (IVIVC) proves to be sound milestones and signifies that we are incessantly forwarding towards a scenario that would reduce regulatory burden, save time and make the drug products more affordable while ensuring their quality. This review outlines, the current and pertinent regulatory environment for biowaiver based on in vitro drug dissolution, primarily as per the FDA perspective. The rationale used for qualification of biowaiver for different strengths, post-approval changes and multi-source products are discussed along with the role of BCS and IVIVC.