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Sandoz’s application for MS biosimilar accepted by FDA

July 25, 2022


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

A marketing authorisation application (MAA) for natalizumab was accepted on 15 July 2022 by the European Medicines Agencies (EMA), as a single disease-modifying therapy (DMT) in adults with highly active RRMS.

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