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Amgen’s Biosimilar Ustekinumab Back on PBAC Agenda

Feb 12, 2026

On 12 February 2026, Australia’s Pharmaceutical Benefits Advisory Committee (PBAC) updated its March 2026 agenda (first published in November 2025) to include consideration for reimbursement of Amgen’s Wezlana®, biosimilar to Janssen’s Stelara® (ustekinumab).

In April 2024, the PBAC recommended  Wezlana® for listing on the Pharmaceutical Benefits Scheme (PBS).  However, Amgen did not proceed with the listing at that time.  Amgen has now come back to the PBAC for consideration of PBS listing of Wezlana® in March 2026.

Wezlana® joins Sandoz’s ustekinumab biosimilar, Ardelya®, on the March 2026 PBAC Agenda, although Ardelya® has not yet received 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 the current status of the application is recorded as “inactive”.