On 1 October 2026, Celltrion’s Avtozma® (tocilizumab), biosimilar to Genentech’s Actemra®, became the first tocilizumab biosimilar to be listed on Australia’s Schedule of Pharmaceutical Benefits (PBS). The PBS listing of Avtozma® will result in a mandatory 25% statutory price reduction for Actemra®.
Avtozma® was the first, and remains the only, tocilizumab biosimilar to be approved in Australia (May 2025). It was launched in Korea in June 2025. in the US (IV formulation) in October 2025, and in Europe in January 2026. The biosimilar has also been granted marketing authorisation in a number of other regions, including Japan (September 2022) and New Zealand (December 2025).
Celltrion additionally had the following products listed on the PBS on 1 October 2026:
- Yuflyma® (adalimumab), biosimilar to AbbVie’s Humira®, in a 20 mg/0.2 mL injection, 2 x 0.2 mL syringes format. Yuflyma® was approved by the TGA in this format in September 2024; and
- Omlyclo® (omalizumab), biosimilar to Genentech’s/Novartis’ Xolair®, for hospital use in 75 mg/0.5 mL injection, 0.5 mL pen device and 150 mg/mL injection, 1 mL pen device formats. Omlyclo® was approved by the TGA in each of these formats in November 2024/August 2025.