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FDA accepts Sandoz’s BLA for biosimilar etanercept

2 October 2015  •  Author: Victoria White

The US Food and Drug Administration (FDA) has accepted Sandoz’s Biologics License Application (BLA) for its proposed biosimilar to Amgen’s US-licensed Enbrel (etanercept) – a tumour necrosis factor alpha (TNF-alpha) inhibitor.


Sandoz is seeking approval for all indications included in the label of etanercept which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.

Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz said, “Anti-TNFs will continue to play a leading role in immunology treatment and the acceptance of our regulatory submission by the FDA today is a significant step towards increasing patient access to these life-changing medicines. We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”

Sandoz currently has five biosimilars in Phase III clinical trials

This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. The BLA consists of a comprehensive data package that includes data from analytical, functional, preclinical and clinical studies. Sandoz believes that the two pivotal clinical studies; a pharmacokinetic (PK) study in healthy volunteers (HVs) and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis (EGALITY), will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.

Sandoz recently launched Zarxio (filgrastim-sndz) – the first biosimilar in the US, signalling a shift toward more competition and affordability in the healthcare system. Sandoz has a leading pipeline with several biosimilars across the various stages of development including five programmes in Phase III clinical trials or registration preparation. The company plans to make ten regulatory submissions in the next three years. 

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