FDA accepts Sandoz application for biosimilar filgrastim

Sandoz is the first company to announce it has filed for approval of a biologic under the biosimilars pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). FDA's acceptance of Sandoz's filing is an important first step in increasing US patient access to affordable, high-quality biologics Sandoz is a global leader in biosimilars with over 50% share of the global biosimilars market Holzkirchen, July 24, 2014 - Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application for filgrastim, which was filed under the new biosimilar pathway created in the Biologics Price Competition and Innovation Act of 2009 (BPCIA). The reference product - Amgen's NEUPOGEN - is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anticancer drugs associated with a significant incidence of severe neutropenia with fever. "This filing acceptance represents a significant step toward making high-quality biologics more accessible in the US and we applaud FDA for its progress in making this a reality," said Mark McCamish, M.D. Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.