On 19 November 2025, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) published its March 2026 agenda, at which the following biosimilars will be considered for reimbursement:
- Amgen’s Amgevita® (adalimumab) in 20mg/0.2ml and 40mg/0.4ml pre-filled syringe (PFS), and 40mg/0.4ml and 80mg/0.8ml pre-filled pen (PFP);
- Celltrion’s Yuflyma® (adalimumab) in 20mg/0.2ml PFS;
- Celltrion’s Omlyclo® (omalizumab) in 75mg/0.5ml and 150mg/1ml PFP; and
- Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS.
Amgen received TGA approval for its high-concentration Amgevita® formulations (referencing AbbVie’s Humira® (adalimumab)) in September 2025. In September 2024, Celltrion’s Yuflyma® was TGA approved in 20mg/0.2ml PFS. Yuflyma® has previously been approved in Australia in 40mg/0.4ml (March 2022) and 80mg/0.8ml (June 2023) forms and was PBS-listed in March 2023 (40mg/0.4ml).
In addition to Celltrion’s Yuflyma® and Amgen’s Amgevita®, there are a number of other high-concentration adalimumab biosimilars approved in Australia, including Alvotech/Cipla’s Ciptunex®/Adalicip® (September 2022), Samsung Bioepis’ Hadlima® (February 2023) and Sandoz’s Hyrimoz® (May 2024).
In September 2025, Celltrion announced the Australian launch of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab). Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in PFS presentations in November 2024 and PBS-listed on 1 August 2025. The PFP formulations which will be considered by PBAC in March 2026 were approved in August 2025.
Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia. While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing. As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025. Samsung Bioepis’ Epyztek® (ustekinumab) was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.