Sandoz regulatory submission for proposed biosimilar adalimumab accepted by FDA

  • Adalimumab is an anti-TNF medicine used to treat a range of immunological diseases[1]
  • The comprehensive data package provided is expected to demonstrate that Sandoz proposed biosimilar adalimumab matches the reference biologic medicine in terms of safety, efficacy and quality[2]-[4]

Holzkirchen, January 16, 2018 – Sandoz, a Novartis division and the global leader in biosimilar medicines, announced today that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA), submitted under the 351 (k …

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