Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept

Sandoz advances its biosimilars program with European Medicines Agency (EMA) acceptance of regulatory submission for biosimilar etanercept [1]

Publish Date:

Aug 12, 2015

Holzkirchen, December 8, 2015 – Sandoz, a Novartis company and the global leader in biosimilars, announced today that the European Medicines Agency (EMA) has accepted their Marketing Authorization Application (MAA) for a biosimilar to Pfizer’s EU-licensed Enbrel® (etanercept) * - a tumor necrosis factor alpha (TNF-α) 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 - more than 120 million people in the EU are living with rheumatic and musculoskeletal diseases (RMDs)1 and approx 3.7 million Europeans with psoriasis.