A Brief Note on Different Concept of Biowaiver

Abstract

The aim of the present work was to understand the concept of to waive a complete and systemic bioequivalence (BE) study. Biowaiver or request for a biowaiver is a fast track approach to boost the drug development process. Over the past three-four years, the biowaiver market has shown greater number of biowaiver submissions and the wider use of in-vitro permeability study. Biowaiver is a beneficial approach for getting approval of abbreviated new drug application (ANDA). While BCS based biowaiver is the novel approach to gain approval for new drug application (NDA), investigate new drug application (IND) as well as ANDA. A biopharmaceutics classification system (BCS) based biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. The current work focuses on different types of biowaiver approaches and the criteria for the applicability of BCS based biowaivers in different geographic scopes with regard to global development strategy. There is a comparison of global guidelines on provisions availability for different types of biowaiver approaches as well as for requirements of biowaiver based on BCS. From comparison of different global guidelines it is reviewed that most of the guidance resembles to the USFDA, EU and WHO guidelines because most of the regulatory authorities are following the BCS based biowaiver concept as one of the three main guidance documents (USFDA, EMA, JP, WHO) or a combination of specific requirements.

Keywords: Bioequivalence, biowaiver, ANDA, NDA, INDA, BCS based biowaiver

Cite this Article

Mudit Dixit, Rohit Dixit, Ganaybn Payya Bairy, et al. A Brief Note on Different Concept of Biowaiver. Research & Reviews: A Journal of Drug Formulation, Development and Production. 2016; 3(3): 22–30p.