European regulators have accepted Sandoz’ marketing application for a biosimilar of Pfizer’s $9-billion-a-year anti-inflammatory Enbrel, the world’s fifth biggest selling drug.
The Novartis group says it is seeking approval for all indications included in Enbrel’s (etancerpt) label, targeting a range of autoimmune diseases including rheumatoid arthritis and psoriasis that affect millions of patients across Europe.
More than 120 million people in the EU are living with rheumatic and musculoskeletal diseases and around 3.7 million with psoriasis, but only around 5% of those with psoriasis have access to “life-changing biologic treatment options”, says Mark McCamish, head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz.
"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,” he noted.
The submission includes data from analytical, functional, preclinical and clinical studies, which the firm said provide confirmation that the biosimilar is highly similar to its reference product.
An application was filed in the US - where Enbrel is sold by Amgen - last month.