Quality standards for biopharmaceuticals: the importance of good manufacturing practice

Abstract

Regulatory standards for rDNA derived medicinal products put in place over 40 years ago provided a framework for moving forward with novel biotechnologies and biosimilars leading to their success as highly effective medicines. As biologicals and biosimilars are increasingly developed, licensed and used worldwide less experienced manufacturers and regulatory agencies need support in dealing with these highly complex products. This Commentary highlights the need for regulatory convergence and support, notes the critical role of GMP and draws attention to the comprehensive review by Sia Chong Hock et al. which strongly advocates improving harmonization of regulatory efforts especially in the Association of South East Asian Nations (ASEAN).