Sandoz biosimilar filgrastim recommended for approval by FDA Oncologic Drugs Advisory Committee

  • Oncologic Drugs Advisory Committee (ODAC) votes in favor of recommending biosimilar filgrastim for approval in the US
  • Biosimilar filgrastim recommended to be approved for use in all requested indications
  • Committee’s recommendation based on review of extensive data from analytical, non-clinical, clinical studies and post-marketing pharmacovigilance

Holzkirchen, January 7, 2015 – Sandoz, a Novartis company, announced today that US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of its …

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