Celltrion Secures the US FDA’s Approval for Avtozma IV (Biosimilar, Actemra) to Treat Cytokine Release Syndrome
Shots:
- The US FDA has approved Avtozma IV, a biosimilar to Actemra (tocilizumab), for treating cytokine release syndrome in pts (≥2yrs.), covering all Actemra IV-approved indications in the US; expected to be available in the US by Aug 31, 2025
- In Jan 2025, the US FDA approved Avtozma IV to treat rheumatoid arthritis (RA), giant cell arteritis (GCA), polyarticular juvenile idiopathic arthritis (pJIA), systemic juvenile idiopathic arthritis (sJIA) & COVID-19
- Additionally, Celltrion holds the commercialization rights of the Avtozma SC formulation in the US, with the licensed launch date remaining confidential
Ref: Celltrion| Image: Celltrion| Press Release
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