Sandoz and Polpharma Biologics announced that the EC has approved Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, as a single disease-modifying therapy (DMT) in adults with highly active Relapsing Remitting Multiple Sclerosis. This is the first EC approved biosimilar to Tysabri®. Tyruko® was developed by Polpharma Biologics, and will be commercialised by Sandoz.
Tyruko® was approved by the FDA on 25 August 2023. The EU CHMP issued a positive opinion recommending approval of Tyruko® on 21 July 2023.