On 16 July 2025, Celltrion announced the results of its global phase 3 trial comparing the efficacy and safety of its tocilizumab biosimilar, Avtozma® (CT-P47), to reference drug, Roche’s Actemra®. The results demonstrated comparable efficacy, pharmacokinetics, safety and immunogenicity between patient groups that maintained the reference product and those that switched to Avtozma®.
Celltrion launched Avtozma® in Korea in June 2025, following its approval in December 2024 for the same indications as Actemra®. Just days earlier, Australia’s Therapeutic Good’s Administration (TGA) approved Avtozma® as the first tocilizumab biosimilar in the country.
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. Avtozma® was also the third tocilizumab biosimilar approved in the US in 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).