A second biosimilar from Apotex is under review in US Food and Drug Administration (FDA)
Canadian Apotex announced on February 13, 2015 that FDA has accepted company application for its biosimilar filgrastim (original brand — Neupogen, Amgen). Filgrastim is a granulocyte colony-stimulating factor used to stimulate neutrophil production in bone marrow of patients undergoing chemotherapy, which allows them to fight off infections. This is a second filgrastim and a second biosimilar from Apotex in review with FDA. Novartis received approval for its Zarzio (filgrastim-sndz) earlier this month, and Apotex filed an application for a pegfilgrastim biosimilar (original brand — Neulasta/Neulastim, Amgen/Roche). Two more biosimilar applications are in review with FDA at this time: infliximab from Celltrion and epoetin alfa from Hospira. Apotex already received approval for its filgratim in EU (brand name — Grastofil). Neupogen global sales amounted to approximately US$1 billion in 2014.
Sources: Generics and Biosimilars Initiative, Vidal