Several biosimilars are positioned for listing on Australia’s Pharmaceutical Benefits Scheme (PBS) from 1 July 2025, namely: Celltrion’s Steqeyma® (ustekinumab, biosimilar to Janssen’s Stelara®), Viatris’ Nepexto® (etanercept, biosimilar to Pfizer’s Enbrel®), Sandoz’s Tyruko® (natalizumab, biosimilar to Biogen’s Tysabri®).
Celltrion’s Steqeyma® is set to become the first biosimilar to Janssen’s Stelara® (ustekinumab) to be listed on the PBS. The product has reached the final “government processes” stage, indicating that PBS-listing is imminent. Steqeyma® was recommended in December 2024 following its consideration at PBAC’s November 2024 meeting. Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for listing at the March 2024 PBAC meeting, however Amgen is not proceeding with the PBS-listing and the PBAC process has ceased. Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but remains in the earlier stages of application.
Viatris’ Nepexto® may soon become the second biosimilar to Pfizer’s Enbrel® (etanercept) subsidised under the PBS, also reaching the final “government processes” stage. Samsung Bioepis/Arrow Pharma’s Brenzys® was the first PBS-listed etanercept biosimilar in April 2017.
Sandoz’s Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab), is also approaching PBS listing, following its recommendation in PBAC’s March 2025 meeting and approval as the first and only natalizumab biosimilar in Australia (April 2025). Tyruko® was developed by Polpharma Biologics and, under a global commercialisation agreement with Sandoz reached in 2019, Sandoz has exclusive rights to commercialise and distribute the product in all markets.