Sandoz biosimilar etanercept recommended by FDA advisory committee for approval to treat multiple inflammatory diseases

  • Committee votes unanimously in favor of the Sandoz proposed biosimilar etanercept for all approved indications of the reference product
  • Committee’s recommendation based on totality of evidence from global development program showing biosimilar etanercept is highly similar to Enbrel®*

Holzkirchen, 13 July, 2016. Sandoz, a Novartis division and leader in biosimilars, announced today that the US Food and Drug Administration (FDA) Arthritis Advisory Committee recommended approval of its proposed biosimilar etanercept. The committee voted unanimously ( …

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