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| Press Release
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