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