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. Currently pending cases are in red. # 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)…