BCS Based Biowaiver (US-ANDA) and Comparative Analysis of Global Regulatory Guidelines

Abstract

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. Over the past three-four years the biowaiver market shows greater number of biowaiver submissions and the wider use of In-vitro permeability study. Biowaiver is a eneficial approach for getting approval of ANDA while, BCS based biowaiver is the novel approach to gain approval for NDA as well as ANDA. A BCS based Biowaiver is an exemption from conducting human bioequivalence studies when active ingredient and dosage form meet criteria of solubility, permeability and dissolution. This Dissertation work covers different kind of biowaiver approaches and the criteria for the applicability of BCS based biowaivers in the 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. From comparison of different global guideline for the requirement criteria of BCS based biowaiver application it is reviewed that most of the guidance conforms to the USFDA, EU and WHO guidelines because most of the countries are following the BCS based biowaiver concept as one of the three main guidance documents (USFDA, EMA, WHO) or a combination of specific requirements. In addition, dossier of BCS based biowaiver requires less data then general ANDA dossier. It includes data that supporting high solubility, high permeability, rapid and similar dissolution and some additional data on excipients and CMC assessment.