Amgen, Apotex hematology, biosimilars news
The U.S. Court of Appeals for the Federal Circuit (CAFC) upheld a lower court ruling granting Amgen a preliminary injunction barring Apotex from launching its biosimilar version of Amgen’s Neulasta pegfilgrastim until 180 days after the biosimilar gains FDA approval. In Amgen Inc. v. Apotex Inc., CAFC ruled 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). CAFC also 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. Late last year, the U.S. District Court for the Southern District of Florida granted Amgen’s motion for preliminary injunction, which Apotex appealed. Amgen recorded $3.9 billion in U.S. 2015 sales of the neutropenia drug (see BioCentury, Dec. 14, 2015). ...