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Approval Alert: EC Approves Sandoz/Polpharma’s Tyruko®, Biosimilar to Biogen’s Tysabri® (natalizumab)

Sep 26, 2023

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 opinionrecommending approval of Tyruko® on 21 July 2023.