The European Medicines Agency (EMA) has accepted the marketing authorization application (MAA) for a Sandoz’s biosimilar to Pfizer’s EU-licensed Enbrel (etanercept), a tumor 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.

The regulatory submission to the EMA consists of a data package that includes data from analytical, functional, pre-clinical,and clinical studies. Sandoz believes that the two clinical studies; a pharmacokinetic study in healthy volunteers and a confirmatory safety and efficacy study in patients with chronic plaque-type psoriasis will provide clinical confirmation of similarity to the reference product established in prior analytical comparability studies.

In September 2015 Sandoz launched the first biosimilar in the United States and recently had its regulatory submissions for biosimilar etanercept and biosimilar pegfilgrastim accepted by the US Food and Drug Administration. Sandoz has a 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 10 regulatory filings over a three year period (2015-2017). Sandoz is part of Novartis.

Source: Novartis