On 16 December 2025, the Australian Therapeutic Goods Administration (TGA) approved Celltrion’s Steqeyma®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two pre-filled pen (PFP) formulations:
- 90 mg/1 mL solution for injection pre-filled pen (500305); and
- 45 mg/0.5 mL solution for injection pre-filled pen (500306).
Steqeyma® was first approved in Australia in September 2024 for the same strengths in pre-filled syringe presentations, as well as a 130 mg/26 ml concentrate in vial. In August 2025, Steqeyma® became the first ustekinumab biosimilar to be PBS listed, and was subsequently launched in September 2025.
There are four other ustekinumab biosimilars approved in Australia: Amgen’s Wezlana® (January 2024) and Ajemnye® (May 2024), Samsung Bioepis’ Epyztek® (October 2024) and Alvotech/Cipla’s Uteknix® (February 2025).
Sandoz’s Ardelya®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), will be considered by PBAC at its March 2026 meeting, although it has not yet received marketing approval in Australia. While Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing. As a result, Celltrion’s Steqeyma® was the first ustekinumab biosimilar to be PBS-listed on 1 August 2025. Samsung Bioepis’ Epyztek® was recommended for PBS-listing at PBAC’s March 2025 meeting, but the current status of the application is recorded as “inactive”.