On 7 October 2026, Celltrion announced that the FDA has approved an additional indication for its IV formulation of Avtozma® (tocilizumab), biosimilar to Roche/Genentech’s Actemra®, for the treatment of COVID-19 in paediatric patients aged 2 years and older. This expands the previous US approved indications for Avtozma®, which included COVID-19 in adults.
Both the intravenous and subcutaneous formulations of Avtozma® were first approved in the US in January 2025, with the IV formulation launched in October 2025. In August 2025, the FDA approved an additional indication for the IV formulation for the treatment of cytokine release syndrome. 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) (March 2024; IV formulation launched April 2024; SC formulation launched July 2024).
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). On 1 October 2026, Celltrion’s Avtozma® became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits, after being recommended for PBS-listing at the November 2025 PBAC meeting.