Dr. Leah Christl, the FDA’s Associate Director for Therapeutic Biologics, Office of New Drugs Therapeutic Biologics and Biosimilars Team at CDER, recently participated in a podcast on biosimilars.  During the discussion, she provided a “snapshot” of the biosimilar landscape at FDA.

According to Dr. Christl, as of February 1, 2017, there are 64 programs enrolled

Introduction

The Biologics Price Competition and Innovation Act (“BPCIA”) created an abbreviated approval pathway for biological products shown to be “highly similar” to already FDA-approved biological products.  By permitting the sponsor of a biological product to rely on data submitted by the holder of an FDA-approved biological product, the BPCIA is somewhat similar in concept