Results Wire: US FDA Advisory Committee Unanimously Supports Proposed Biosimilar to Amgen’s Neupogen by Sandoz, the First to Test a New Abbreviated Pathway for Biosimilars – JAN 7, 2015 (ODAC)

On Wednesday, January 7, 2015, the Oncologic Drugs Advisory Committee (ODAC) unanimously supported, by a vote of 14-Yes to 0-No, with no abstentions, the safety and efficacy of EP2006, a proposed biosimilar to Amgen Inc.'s Neupogen (filgrastim), submitted by Sandoz, Inc. The proposed indications for this product are the same as Neupogen’s and are: (1) To decrease the incidence of infection‚ as manifested by febrile neutropenia‚ in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a significant incidence of severe neutropenia with fever; (2) for reducing the time to neutrophil recovery and the duration of fever, following induction or consolidation chemotherapy treatment of adults with acute myeloid leukemia; (3) to reduce the duration of neutropenia and neutropenia-related clinical sequelae‚ e.g.‚ febrile neutropenia in patients with nonmyeloid malignancies undergoing myeloablative chemotherapy followed by marrow transplantation; (4) for the mobilization of hematopoietic progenitor cells into the peripheral blood for collection by leukapheresis; and (5) for chronic administration to reduce the incidence and duration of sequelae of neutropenia (e.g.‚ fever‚ infections‚ oropharyngeal ulcers) in symptomatic patients with congenital neutropenia‚ cyclic neutropenia‚ or idiopathic neutropenia.

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