Sandoz Receives EC’s Marketing Authorization for Biosimilar Tyruko to Treat Multiple Sclerosis
Shots:
- The EC has granted marketing authorization for the first and only biosimilar Tyruko to treat relapsing forms of MS. Tyruko was developed by Polpharma Biologics & will be commercialized by its collaboration partner Sandoz
- The decision was based on evidence from extensive analytical characterization in addition to P-I & confirmatory P-III studies. Both studies met their 1EPs & showed similarity of the biosimilar with reference biologic in terms of PK, efficacy, safety & immunogenicity
- In 2019, Sandoz & Polpharma Biologics collaborated for biosimilar natalizumab where Polpharma Biologics will maintain responsibilities for the development of medicine, manufacturing & supply of drug substances. Sandoz gets the rights to commercialize & distribute in all markets
Ref: Globenewswire | Image: Sandoz
Related News:- Sandoz’ Tyruko (biosimilar, natalizumab) Receives the US FDA’s Approval as First Biosimilar for Relapsing Forms of Multiple Sclerosis
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