On 3 October 2025, Celltrion announced that it has launched its intravenous formulation of Avtozma®/CT-P47, biosimilar to Roche’s Actemra® (tocilizumab), in the United States. Avtozma® IV is indicated for all reference indications, with the FDA approving an indication extension for the treatment of cytokine release syndrome (CRS) in August 2025.
Avtozma® is the third tocilizumab biosimilar approved in the US (January 2025). Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024; IV formulation launched April 2024; SC formulation launched July 2024).
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.