Amgen, Apotex hematology, biosimilars news
The U.S. District Court for the Southern District of Florida granted a preliminary injunction barring Apotex from launching its biosimilar version of Amgen’s Neulasta pegfilgrastim until 180 days after the biosimilar gains FDA approval. The court order also requires Apotex to notify Amgen when and if its biosimilar of the neutropenia drug is approved by FDA.
The ruling echoes a July decision by the U.S. Court of Appeals for the Federal Circuit (CAFC), which concluded that the Biologics Price Competition and Innovation Act (BPCIA) requires the manufacturer of a biosimilar to give its reference product’s sponsor 180 days’ notice before launching the biosimilar and can only give such notice after FDA has approved the biosimilar. According to Amgen, Apotex provided Amgen with the BLA and manufacturing information for the biosimilar, leading Amgen to file a patent infringement suit against Apotex in August. Amgen’s suit also said Apotex provided its notice of commercial marketing to Amgen on April 17, prior to the biosimilar’s FDA approval. ...