Sandoz, a Novartis company and the global leader in biosimilars, announced that 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 tumour necrosis factor alpha (TNF-alpha) inhibitor. This is the second BLA submission by Sandoz using the 351(k) biosimilar pathway.
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 affecting approx. 1.3 million and 7.5 million people (respectively) in the US.
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 has a leading pipeline with several biosimilars across the various stages of development including five programmes in phase III clinical trials or registration preparation. Sandoz recently launched Zarxio (filgrastim-sndz) - the first biosimilar in the United States, signaling a shift toward more competition and affordability in the healthcare system.
Subscribe to PharmaTutor News Alerts by Email >>
