Biosimilars 2017 Year in Review


Since the passage of the Biologics Price Competition and Innovation Act (BPCIA), 2017 has been the most active year yet for drug manufacturers. Fish attorneys Tasha Francis, Jenny Shmuel, and Brianna Chamberlin addressed the guidance and changes of 2017 in a recent article titled "Biosimilars 2017 Year in Review" featured in the Bloomberg Law Pharmaceutical Law & Industry Report®.

The article reviews the guidance from the Supreme Court and the Federal Circuit on the bounds of the BPCIA and discusses the greatly anticipated FDA draft guidance on biosimilar interchangeability.

On February 7, 2018, the head of Fish's regulatory practice, Terry Mahn, testified in front of the U.S. Senate Special Committee on Aging and referenced this article as a resource for more information. Video of this testimony can be found here.

Click here to read the full article.