On June 10, 2020, the U.S. Food and Drug Administration (FDA) approved Pfizer’s NYVEPRIA (pegfilgrastim-apgf), a biosimilar of Amgen’s NEULASTA. NYVEPRIA is indicated to “decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of…
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…
Pending U.S. District Court BPCIA Litigations Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal Amgen v. Hospira, Nos. 18-1064, 20-561 (D. Del.) NIVESTYM (filgrastim-aafi) [approved] [launched] NEUPOGEN [litigation #4] July 18, 2018 Pending – jury trial scheduled for May 17, 2021 Immunex v. Samsung Bioepis, No….