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Approval Alert: Alvotech/Cipla’s Ustekinumab Biosimilar Approved in Australia

Feb 11, 2025

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:

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.