Celltrion USA Seeks Approval for Actemra Biosimilar.

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    • Abstract:
      The article focuses on Celltrion USA's completion of the biologic license application (BLA) for CT-P47, a biosimilar of Genentech's Actemra based on data from a phase 3 trial in rheumatoid arthritis patients. Topics include the efficacy, safety, and immunogenicity of CT-P47, its potential approval in both intravenous and subcutaneous routes, and the increasing competition in the biosimilar market with Biogen's Tofidence recently approved as the first biosimilar to Actemra.