On February 11, 2020 Amgen sued Pfizer and its affiliate Hospira for patent infringement based on their proposed biosimilar of NEULASTA (pegfilgrastim).  Pegfilgrastim is indicated for decreasing the incidence of infection in patients receiving myelosuppressive chemotherapy.  In the complaint, Amgen alleges that Hospira’s aBLA infringes U.S. Patent No. 8,273,707 (“the ’707 patent”), directed at methods of protein purification.  The complaint alleges that the parties agreed that the ’707 Patent would be the subject of an action for patent infringement under 42 U.S.C. § 262(l)(6), 15 days after beginning their negotiations under 42 U.S.C. § 262(l)(4)(A).

Three pegfilgrastim biosimilars have already launched in the U.S., including Mylan’s FULPHILA (pegfilgrastim-bmez), Coherus’s UDENYCA (pegfilgrastim-cbqv), and Sandoz’s ZIEXTENZO (pegfilgrastim-bmez).  All three previous biosimilars were the subject of BPCIA litigations that were resolved last year, with  Coherus and Sandoz winning on appeal that their proposed biosimilars would not infringe Amgen’s patents, and Mylan receiving a stipulated judgment of non-infringement for Amgen’s patents.