Can a Two-Pronged Attack from Congress and the FDA Make Up for the BPCIA’s Limitations?
Guodong Fu The Biologic Product Competition and Innovation Act (BPCIA) of 2009, modeled after the Hatch-Waxman Act of 1984, has been largely criticized as ineffective in promoting significant competition in the pharmaceutical industry. Biosimilar sponsors lack guidance from the U.S. Food and Drug Administration (FDA) on how to obtain interchangeable designation for follow-on biologics. In addition, biosimilar sponsors face patent infringement litigation from reference drug companies as part of the “patent dance” set forth by the Supreme Court in 2017 in Sandoz v. Amgen. The FDA’s Biosimilar Action Plan (BAP) and a proposed bill from Congress, the Biologic Patent Transparency...