BLAs for multiple sclerosis biosimilar natalizumab accepted by FDA and EMA

Swiss pharma giant Novartis’ (NOVN: VX) generic and biosimilar medicines unit Sandoz announced today that the US Food and Drug Administration (FDA) has accepted its biologics license application (BLA) for a proposed first-of-a-kind biosimilar natalizumab, developed by Polpharma Biologics.

The application includes all indications covered by the reference medicine, Biogen’s (Nasdaq: BIIB) Tysabri (natalizumab), for relapsing forms of multiple sclerosis (MS) including clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), active secondary progressive disease in adults, and Crohn´s disease.

The European Medicines Agency (EMA) also accepted the marketing authorization application (MAA) for this proposed biosimilar natalizumab, as announced on July 15, covering treatment as a single disease-modifying therapy (DMT) in adults with highly active RRMS, the same indication as approved by the EMA for reference medicine Tysabri.