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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

Related News:- Celltrion Launches Osenvelt and Stoboclo (Biosimilars, Xgeva and Prolia) in the US

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