FDA Accepts Sandoz Regulatory Submission for a Proposed Biosimilar Etanercept

Sandoz, a Novartis company and the global leader in biosimilars, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) under the 351 (k) pathway for its proposed biosimilar to Amgen’s US-licensed Enbrel® (etanercept) – a tumor necrosis factor alpha (TNF-alpha) inhibitor.

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