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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Neha is a Senior Editor at PharmaShots. She is passionate and very enthusiastic about recent updates and developments in the life sciences and pharma industry. She covers Biopharma, MedTech, and Digital health segments along with different reports at PharmaShots. She can be contacted at connect@pharmashots.com.
