BioCentury
ARTICLE | Politics & Policy

SCOTUS declines to review Apotex biosimilar case

December 13, 2016 1:14 AM UTC

The U.S. Supreme Court denied a petition from Apotex Inc. (Toronto, Ontario) asking it to review a lower court ruling that prevents the launch of a biosimilar until 180 days after FDA approval. The July decision by the U.S. Court of Appeals for the Federal Circuit (CAFC) held that a 180-day premarketing notice requirement outlined in the Biologics Price Competition and Innovation Act (BPCIA) applies to biosimilar applicants that have exchanged patent information with reference biologic manufacturers (see BioCentury Extra, July 6)...