On 6 August 2025, Celltrion announced that the US FDA has approved an expanded indication for its IV formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), for the treatment of cytokine release syndrome (CRS) in adults and paediatric patients aged 2 years and older. With this approval, Avtozma® IV now aligns with all reference indications of Actemra® IV in the US.
Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025), trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).
In February 2025, Avtozma® became the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms in November 2023, and Biogen’s IV Tofidence® in June 2024.
Celltrion’s Avtozma® is the first and only tocilizumab biosimilar to be approved in Australia (May 2025) and will be considered for PBS-listing at PBAC’s November 2025 meeting.