At the March 2026 PBAC Meeting (outcomes published on 24 April 2026), the Australian Pharmaceutical Benefits Advisory Committee (PBAC) recommended reimbursement of the following biosimilars:
- 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;
- Sandoz’s Ardelya® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS;
- Amgen’s Wezlana® (ustekinumab) in 45mg/0.5ml and 90mg/1ml PFS and 130 mg in 26 mL solution for IV infusion.
Amgen’s high concentration adalimumab biosimilar, Amgevita®, was TGA-approved in September 2025, while Celltrion’s high concentration adalimumab Yuflyma® was TGA-approved in September 2024, June 2023 and March 2022 as 20mg/0.2ml PFS, 80mg/0.8ml and 40mg/0.4ml, respectively. Yuflyma® was first PBS-listed in March 2023 (40mg/0.4ml). There are a number of other high concentration biosimilars to AbbVie’s Humira® approved in Australia, including Samsung Bioepis’ Hadlima® (approved February 2023, PBS-listed by Organon October 2024) and Sandoz’s Hyrimoz® (approved May 2024 and PBS-listed January 2025).
Celltrion’s Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, was previously PBS-listed on 1 August 2025 (in 75 mg/0.5ml and 150 mg/1ml PFS) and was launched in Australia in September 2025. The March 2026 PBAC recommendation relates to the pre-filled pen presentation, which was TGA approved in August 2025.
Amgen’s Wezlana® (ustekinumab), biosimilar to Janssen’s Stelara®, was first recommended for PBS listing at PBAC’s April 2024 meeting. However, Amgen did not proceed with the listing at that time and requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting. PBAC has extended its March 2024 recommendation for a further 12 months, supporting the PBS listing of Wezlana®.
Sandoz’s Ardelya® (ustekinumab) has also been recommended for PBS listing but is yet to receive marketing approval in Australia.
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 has not yet progressed to PBS listing, pending lodgement of required documentation.