On 4 September 2025, Celltrion announced that it has launched Steqeyma® (ustekinumab) and Omlyclo® (omalizumab) in Australia, biosimilars to J&J/Janssen’s Stelara® and Novartis’ Xolair®, respectively. On 1 August 2025, Arrotex announced its strategic licensing agreement with Celltrion for the Australian commercialisation of Celltrion’s ustekinumab and omalizumab biosimilars.
The Arrotex announcement came on the same day that Steqeyma® became the first ustekinumab biosimilar to be PBS-listed (1 August 2025). Although Amgen’s Wezlana® was the first ustekinumab biosimilar recommended for PBS-listing in March 2024, Amgen is no longer proceeding with that listing. 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”.
Celltrion’s Omlyclo® is currently the only omalizumab biosimilar approved in Australia, having first been approved in pre-filled syringe (PFS) presentations in November 2024 and was (together with Steqeyma®) PBS-listed on 1 August 2025. In August 2025, Australia’s Therapeutic Goods Administration (TGA) approved Omlyclo® in two pre-filled pen (PFP) presentations (75.mg/0.5ml and 150mg/ml).