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…
The table below chronologically lists the U.S. patent litigations filed under the BPCIA regarding aBLAs for biosimilar products. # Litigation Accused Biosimilar [status] Reference Product Complaint Filed Status/Outcome District Court Appeal 1 Amgen v. Sandoz, No. 14-474 (N.D. Cal.) [consolidated with #7 below] ZARXIO (filgrastim-sndz) [approved; launched] NEUPOGEN [litigation #1]…