The FDA Biosimilar Action Plan: Making Biologics More Accessible

Sarfaraz K. Niazi, PhD

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

December 07, 2018

The Biologics Price Competition and Innovation Act of 2009 (BPCIA) created a new category of biological products, biosimilars, which have similar safety and efficacy profiles as US-licensed reference products. The BPCIA was approved as part of the Affordable Healthcare Act.

Now, a decade later, the FDA has approved only 15 biosimilar products, most of which are not yet launched for legal reasons, and the FDA has yet to approve its first interchangeable biologic product. This pace of market entry is much slower than what the FDA had anticipated. The reasons for the slow entry of biosimilars are many, and I was able to analyze, summarize, and publish my findings recently (in the European Pharmaceutical ReviewGaBI Journal, and BioProcess International) based on my firsthand experience in developing biosimilars.

I sent these publications to the FDA, and a few months later, I filed a citizen petition wherein I provided a detailed scientific thesis on why the existing guidance is impeding the development of biosimilars.