Clinical Pharmacology – Biomolecular
Biosimilar product development is a growing and evolving area that presents various challenges to sponsors and regulators alike. In fact, biosimilar development programs and applications generally each raise unique scientific and regulatory issues. Since the passing of the BPCI Act by Congress in 2010, FDA has approved 12 biosimilar applications, for which some are 2nd and 3rd biosimilars to a FDA-licensed reference product. To ensure overarching success of biosimilar programs, sponsors, regulators, lawmakers, patients, and the healthcare community at large each have a role to play in understanding and minimizing barriers. The presentation will aim to 1) describe the biosimilar regulatory framework through case examples, and 2) from a regulatory perspective, elucidate upon steps aimed at minimizing barriers for biosimilar approvals.