On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations:
- 90 mg/1 mL solution for injection pre-filled syringe (422260); and
- 45 mg/0.5 mL solution for injection pre-filled syringe (422259).
Both formulations are indicated for:
- the treatment of adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; and
- alone or in combination with methotrexate, for the treatment of signs and symptoms of active psoriatic arthritis in adult patients where response to previous non-biological DMARD therapy has been inadequate.
Uteknix® has not been approved for Crohn’s disease or ulcerative colitis, or patients under the age of 18 years.
Uteknix® is being commercialised by Cipla in Australia pursuant to a 2021 agreement with Alvotech in relation to its ustekinumab biosimilar, AVT04.
This approval makes Uteknix® the fifth ustekinumab biosimilar approved in Australia, following Samsung Bioepis’ Epyztek® (October 2024), Celltrion’s SteQeyma®/CT-P43 (September 2024) and Amgen’s Ajemnye® (May 2024) and Wezlana® (January 2024).
Stelara® remains the only PBS-listed ustekinumab product at this stage, but that can be expected to change in the near future. Amgen’s Wezlana® was recommended for listing at the March 2024 PBAC meeting, but has not yet been added to the PBS. Celltrion’s SteQeyma® was recommended for PBS-listing at PBAC’s November 2024 meeting, while Samsung Bioepis’ Epyztek® will be considered at PBAC’s March 2025 meeting.