On 4 December 2025, New Zealand’s Medsafe approved Celltrion’s Avtozma®, biosimilar to Roche’s Actemra® (tocilizumab), in vial (intravenous) and pre-filled syringe (subcutaneous) presentations, making Avtozma® the first tocilizumab biosimilar approved in New Zealand.
Avtozma® has previously been granted marketing authorisation in a number of other regions, including as the first tocilizumab biosimilar approved in Australia (May 2025) and Japan (September 2022), and will be considered for listing on Australia’s PBS at PBAC’s November 2025 meeting.
Avtozma® was the third tocilizumab biosimilar approved in the US (January 2025), and was subsequently launched in an IV formulation in October 2025. Biogen/Bio-Thera’s Tofidence®/BAT1806 was the first US approved tocilizumab biosimilar (IV formulation, September 2023; launched May 2024), followed by Fresenius Kabi’s Tyenne® (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.