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

Related News:- Fresenius Kabi’s Tyenne (biosimilar, tocilizumab) Receives EC’s Approval for Multiple Inflammatory and Immune Mediated Conditions

PharmaShots! Your go-to media platform for customized news ranging for multiple indications. For more information connect with us at connect@pharmashots.com