FDA News Release (03/06/15)

The U.S. Food and Drug Administration (FDA) approved on March 6 Zarxio (filgrastim-sndz), the first biosimilar product in the United States. The drug, from Sandoz, is biosimilar to Amgen's Neupogen (filgrastim), which was licensed in 1991. Zarxio--which is approved for the same indications as Amgen's drug--can be prescribed for patients with cancer receiving myelosuppressive chemotherapy; patients with acute myeloid leukemia receiving induction or consolidation chemotherapy; patients with cancer undergoing bone marrow transplantation; patients undergoing autologous peripheral blood progenitor cell collection and therapy; and patients with severe chronic neutropenia. "Biosimilars will provide access to important therapies for patients who need them," said FDA Commissioner Margaret A. Hamburg. "Patients and the health care community can be confident that biosimilar products approved by the FDA meet the agency's rigorous safety, efficacy, and quality standards."

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