FDA accepts Sandoz submission for Amgen biosimilar
Sandoz, a Novartis company and a global leader in biosimilars, has announced today that the US Food and Drug Administration (FDA) has accepted its 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 Amgen’s reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis, which affect some 1.3 million and 7.5 million people in the US respectively.
Mark McCamish, head of global biopharmaceutical & oncology injectables development at Sandoz, comments: “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.” He adds: “We believe we are the first company to receive FDA file acceptance of a biosimilar version of etanercept.”
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, pre-clinical 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 said it has an unwavering commitment to increasing patient access to high-quality, life-enhancing biosimilars. The company currently markets three biosimilars and recently launched Zarxio (filgrastim-sndz) – the first biosimilar approved in the United States, which it says indicates a shift toward increased competition and affordability in the healthcare system.
Sandoz has a leading pipeline, with several biosimilars across the various stages of development, including five programs in Phase III clinical trials or registration preparation. The company plans to make 20 regulatory submissions in the next three years.
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