Sandoz files BLA at FDA for etanercept biosimilar

Sandoz announced that the FDA has accepted its Biologics License Application (BLA) under the 351(k) pathway for its proposed biosimilar to Amgen's Enbrel (etanercept) – a tumour necrosis factor alpha (TNF-alpha) inhibitor. Sandoz is seeking approval for all indications included in the label of the reference product which is used to treat a range of autoimmune diseases including rheumatoid arthritis and psoriasis.

This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway. This 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 study in healthy volunteers and a confirmatory safety and efficacy study (EGALITY) in patients with chronic plaque psoriasis, will provide confirmation of similarity to the reference product established in prior analytical comparability investigations.