On 1 August 2025, the Pharmaceutical Benefits Scheme (PBS) published its Summary of Changes, which includes the following:
- Sandoz’s Wyost® and Jubbonti®, the first biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) to be PBS listed;
- Celltrion’s Steqeyma®, the first biosimilar to Janssen’s Stelara® (ustekinumab) to be PBS listed; and
- Celltrion’s Omlyclo®, the first biosimilar to Genentech/Novartis’ Xolair® (omalizumab) to be PBS listed.
Each of these biosimilars is PBS listed for all reference indications.
On the same day, Arrotex Pharmaceuticals announced that it has entered into a strategic licensing agreement with Celltrion to commercialise the Celltrion ustekinumab and omalizumab biosimilars in Australia.
Celltrion’s Omlyclo® is the only omalizumab biosimilar approved in Australia (November 2024), and was recommended for reimbursement at PBAC’s March 2025 meeting. Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark reportedly have omalizumab biosimilars under development.
Sandoz’s Wyost® and Jubbonti® and Celltrion’s Steqeyma® were recommended for listing in Australia at the November 2024 PBAC meeting.
Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing at the March 2024 PBAC meeting, but Amgen is not proceeding with the PBS-listing and the PBAC process has ceased. Samsung Bioepis’ ustekinumab biosimilar, Epyztek®, was recommended for PBS-listing at PBAC’s March 2025 meeting. However, the current status of the PBS application indicates that it is inactive as Samsung Bioepis has not advised whether it intends to proceed or not within 60 days of receiving the ratified PBAC minutes.
At the November 2025 meeting, PBAC will consider Celltrion’s denosumab biosimilars, Stoboclo® and Osenvelt® for PBS-listing for all reference indications.