Briefing Summary: US FDA Posts Advisory Committee Materials for Sandoz’s Proposed Biosimilar to Amgen’s Neupogen – JAN 7, 2015 (ODAC)
The US FDA has posted details, including company and FDA Briefing Materials, for the Wednesday, January 7, 2015 Oncologic Drugs Advisory Committee (ODAC) Meeting. The committee will discuss biologics license application (BLA) 125553 for EP2006, a proposed biosimilar to Amgen Inc.'s Neupogen (filgrastim), submitted by Sandoz, Inc. The proposed indications (uses) for this product are notably the same as Neupogen’s. They 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.