On 17 March 2026, Celltrion announced that the subcutaneous (SC) formulation of Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), is now available in the US. The SC formulation is approved for rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis. Avtozma® SC formulation is available in a single-dose prefilled syringe or a single-dose prefilled autoinjector.
Both the subcutaneous and intravenous formulations of Avtozma® were FDA approved in January 2025, with the IV formulation launched in October 2025. In December 2025, Celltrion secured reimbursement coverage for Avtozma® IV in the US, with patient reimbursement available from January 2026.
Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) was the first US approved tocilizumab biosimilar (IV formulation approved September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation approved March 2024; IV formulation launched April 2024; SC formulation launched July 2024). Fresenius Kabi’s Tyenne® SC was the first SC tocilizumab formulation to launch in the US.
Celltrion’s Avtozma® was the first tocilizumab biosimilar to be approved in Korea in December 2024. In the same month, Avtozma® received a positive recommendation by the EMA’s CHMP and subsequently gained European Commission approval in February 2025. The biosimilar has also been granted marketing approval in other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025), Japan (September 2022) and New Zealand (December 2025). It was recommended for listing on Australia’s Pharmaceutical Benefits Scheme at PBAC’s November 2025 meeting.