Sandoz gets EMA acceptance for its biosimilars version of Pfizer's Enbrel

Sandoz, the generics and biosimilars business of Swiss pharma giant Novartis (NOVN: VX) said the European Medicines Agency has accepted its Marketing Authorization Application (MAA) for a biosimilar version of US pharma giant Pfizer's (NYSE: PFE) Enbrel (etanercept) to treat a range of autoimmune diseases.

Dr Mark McCamish, head of global biopharmaceutical & oncology injectables development at Sandoz, said:"Today, only 5% of severe psoriasis patients in North America and Europe have access to life-changing biologic treatment options such as etanercept. The acceptance by the EMA of our biosimilar etanercept regulatory submission is a move towards enabling more patients with chronic inflammatory conditions such psoriasis and rheumatoid arthritis to be treated with biologics."

Sandoz is seeking approval for all indications included in the label of the reference product. More than 120 million people in the EU are living with rheumatic and musculoskeletal diseases and about 3.7 million Europeans with psoriasis.