On 9 October 2025, New Zealand’s Medsafe approved Celltrion’s Steqeyma®, biosimilar to Janssen’s Stelara® (ustekinumab), in vial and pre-filled syringe presentations, making Steqeyma® the first ustekinumab biosimilar approved in New Zealand.
Celltrion’s Steqeyma® has been approved and launched in a number of regions, including Korea (approved June 2024), Canada (approved July 2024, launched August 2024), the EU (approved September 2024, launched November 2024), the UK (approved September 2024, launched December 2024), Australia (approved September 2024, launched September 2025), the US (approved December 2024, launched March 2025), and Japan (approved March 2025, launched July 2025).
In August 2025, Steqeyma® became the first ustekinumab biosimilar to be listed on Australia’s Pharmaceutical Benefits Scheme (PBS).