Biogen Receives EMA’s CHMP Positive Opinion for Tofidence (Biosimilar, Roactemra)
Shots:
- The EMA’s CHMP has issued a positive opinion recommending approval of Tofidence (Biosimilar, Roactemra; IV) to treat moderate to severely active RA, PJIA, SJIA, and COVID-19
- The opinion was based on evidence from extensive analytical characterization and PK, safety & immunogenicity of TOFIDENCE including the P-I study examined healthy volunteers compared to the EU and US reference tocilizumab, & P-III study of TOFIDENCE vs. tocilizumab in methotrexate-insufficiently managed RA patients
- In Apr’21, Biogen and Bio-Thera signed a license agreement for TOFIDENCE. Under which, Biogen holds exclusive rights to regulate, manufacture, and commercialize TOFIDENCE in all countries excluding China, Hong Kong, Macau, and Taiwan
Ref: Biogen | Image: Biogen
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Disha is a content writer at PharmaShots. She is passionate and curious about recent updates and developments in MedTech and Pharma industry. She covers news related to clinical trial results and updates. She can be contacted at connect@pharmashots.com.