FDA, IP, and FTC Developments in the Run-up to the First US Biosimilar Approval

February 11, 2014

As we near the fourth anniversary of the enactment of the Biologics Price Competition and Innovation Act, which established the first abbreviated approval route for follow-on biologics in the United States, multiple federal agencies, the courts, industry participants, and public advocacy groups are accelerating their engagement over the statutory approval mechanism, its regulatory implementation, and new state-level efforts to fill gaps left unaddressed by the Act.

Read "FDA, IP, and FTC Developments in the Run-up to the First U.S. Biosimilar Approval."