ARTICLE | Politics & Policy

CAFC biosimilars ruling focuses eyes on SCOTUS

July 7, 2016 12:29 AM UTC

A federal court's decision reaffirming that biosimilars cannot be launched until 180 days after FDA approval is focusing renewed attention on efforts to persuade the U.S. Supreme Court to consider the issue.

The U.S. Court of Appeals for the Federal Circuit (CAFC) ruled Wednesday in Amgen Inc. v. Apotex Inc. that the 180-day premarketing notice requirement applies to biosimilar applicants that have exchanged patent information with reference biologic manufacturers according to terms of the Biologics Price Competition and Innovation Act (BPCIA). The court ruled the 12 years of marketing exclusivity provided in BPCIA is a minimum, not a maximum. It also suggested FDA could approve biosimilars 11.5 years after an original biologic's approval, effectively creating a 12-year exclusivity period including the 180-day notice period. ...