On 21 April 2026, Celltrion announced that the intravenous (IV) formulation of Steqeyma® (ustekinumab), biosimilar to Janssen’s Stelara®, has been approved in Japan. The newly approved formulation adds to Celltrion’s subcutaneous (SC) formulation of Steqeyma®, which was launched in Japan in July 2025 following its March 2025 approval.
Both formulations of Steqeyma® are approved in Japan for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s Disease.
Celltrion’s SC formulation of Steqeyma® was the third ustekinumab biosimilar launched in Japan, following Alvotech/Fuji Pharma’s launch of AVT04 in May 2024 and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, launched in May 2025. Samsung Bioepis received Japanese approval for its ustekinumab biosimilar, Nipro™, in December 2025.
Steqeyma® has been launched around the world including in the US (March 2025), Europe (November 2024), and Australia (listed on the PBS from 1 August 2025).