On 1 July 2026, Australia’s Pharmaceutical Benefits Scheme published its Summary of Changes, which includes a newly PBS-listed ustekinumab biosimilar and new or expanded PBS-listings for a number of biopharmaceuticals.
The newly PBS-listed ustekinumab biosimilar is Amgen’s Wezlana®, biosimilar to Janssen’s Stelara®, which is PBS-listed for the treatment of inflammatory conditions. Wezlana® was approved by the TGA in January 2024 and was recommended by PBAC for PBS listing in April 2024, although Amgen did not proceed with the PBS listing at that time. Amgen requested PBS listing of Wezlana® be put back on the agenda at the March 2026 PBAC meeting and PBAC then extended its March 2024 recommendation for a further 12 months.
The only other ustekinumab biosimilar currently PBS-listed in Australia is Celltrion’s Steqeyma® (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. Sandoz’s Ardelya® (ustekinumab) was recommended for PBS listing at the March 2026 PBAC meeting but is yet to receive marketing approval in Australia.
The biopharmaceuticals PBS-listed from 1 July 2026 include:
- Novo Nordisk’s Tresiba® Penfill® (insulin degludec) for the treatment of type 1 diabetes, which was originally rejected for PBS listing back in March 2013 due to safety and cost considerations;
- UCB’s Rystiggo® (rozanolixizumab) for treatment of generalised myasthenia gravis (gMG), which was recommended by PBAC for reimbursement in March 2025; and
- AstraZeneca’s Tezspire® (tezepelumab) for the treatment of severe uncontrolled asthma, which was recommended for reimbursement in November 2025 after AstraZeneca had withdrawn an earlier PBAC listing request in July 2022.
In addition, Roche’s PBS listing for Perjeta® (pertuzumab) has been expanded to include the treatment of high-risk HER2+ early breast cancer. Perjeta® was first approved by the TGA in May 2016 and the new indication was recommended by the PBAC for reimbursement in March 2025.