Sandoz receives positive CHMP opinion for multiple sclerosis biosimilar

Sandoz, a Novartis division, announced that the Committee for Medicinal Products for Human Use, or CHMP, of the European Medicines Agency has adopted a positive opinion for marketing authorization for “first-of-a-kind” biosimilar natalizumab developed by Polpharma Biologics. “The authorization covers treatment as a single disease-modifying therapy in adults with highly active relapsing-remitting multiple sclerosis, the same indication as approved by the EMA for the reference biologic. Sandoz entered into a global commercialization agreement for biosimilar natalizumab with Polpharma Biologics in 2019. Under this agreement, Polpharma Biologics will maintain responsibilities for development of medicine, manufacturing, and supply of drug substance. Through an exclusive global license, Sandoz has the rights to commercialize and distribute it in all markets,” the company stated.