Sandoz & Polpharma Announce FDA and EMA Acceptance of Applications for Natalizumab Biosimilar

Sandoz announced this week that the U.S. Food and Drug Administration (FDA) has accepted the first-ever biologics license application (BLA) for a proposed natalizumab biosimilar to Biogen’s TYSABRI®.  The proposed natalizumab biosimilar is for treatment of adults with highly active relapsing-remitting multiple sclerosis (RRMS).  The application is for an intravenous (IV) route of administration, with the same dosing regimen, presentation and indication as TYSABRI®.  Last week, the EMA also accepted a marketing approval authorization (MAA) for Sandoz’s proposed biosimilar natalizumab

The proposed biosimilar natalizumab was developed by Polpharma Biologics, a global biotech company focused on the development and manufacture of biosimilar medicines.  Polpharma retains responsibility for the manufacturing and supply of the product, and Sandoz has the exclusive rights to commercialize and distribute the proposed biosimilar under the terms of a 2019 agreement between the two companies.