FDA panel unanimously backs biosimilar Zarxio
FDA's Oncologic Drugs Advisory Committee voted 14-0 to recommend approval of Zarxio ( EP2006) G-CSF from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN), a biosimilar of neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN). The panel recommended Zarxio for all five indications for which the reference product is approved. Zarxio is the first biosimilar to come before an advisory committee.
Neupogen, a recombinant methionyl human granulocyte colony-stimulating factor, is approved to treat cancer patients receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; cancer patients receiving bone marrow transplant; patients undergoing peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia. ...