Shots:
- The EC has approved Tofidence (IV), a biosimilar version of Roactemra, to treat moderate to severe active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, systemic juvenile idiopathic arthritis and COVID-19
- The approval was based on clinical data showing the similarity of Tofidence vs Roactemra evaluated under the P-I study among healthy participants and P-III trial among individuals with rheumatoid arthritis inadequately controlled by methotrexate
- Additionally, Biogen is responsible for the commercialization of Tofidence across the globe excl. China (incl. Hong Kong, Macau and Taiwan) as per an agreement between Biogen and Bio-Thera signed in Apr 2021
Ref: Biogen | Image: Biogen | Press Release
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