FDA accepts Sandoz application 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 market1

Holzkirchen, July 24, 2014 – Sandoz, a Novartis Group company, announced today that the US Food and Drug Administration (FDA) has …

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