Comparative analysis of biopharmaceutic classification system (BCS) based biowaiver protocols to validate equivalence of a multisource product

Abstract

Biopharmaceutic classification system (BCS) is a substantial part of drug designing and generic product development and has been accepted as a technique to renounce in-vivo pharmacokinetic evaluation (biowaiver). It appeared to be worthwhile and time-saving by means of in-vitro studies in the presence of biorelevant physiological mediums that mimic not only the predictable solubility but also permeability of the multisource product. Such methodology is now applied as a regulatory stamp to support new and generic product approvals based on other than in-vivo equivalence testing. This article outlines the foundation of BCS, its implementation in granting biowaiver, adequacy of in-vitro bioequivalence studies, principles and requirements of BCS biowaiver by four regulatory agencies such as; Food and Drug Authority (FDA), World Health Organization (WHO), European medicine agency (EMA) and International Conference on Harmonization (ICH), potential effect of excipients on solubility and permeability of drug molecules and supplementary data provided by FDA regarding biowaiver approvals. Furthermore, supportive data provided by the International Pharmaceutical Federation (FIP) has also been given for biowaiver sanction of certain drug products. It has been concluded, that although biowaiver is a profitable methodology for generic and new drug product approval, the variance in the standards of governing bodies demands more critical assessment to establish some unified principles to be followed globally. Key words: Biopharmaceutics classification system, bioequivalence, biowaiver.