On 3 September 2026, Samsung Bioepis announced that its Ustekinumab BS Intravenous Infusion [NIPRO] (SB17), biosimilar to Janssen’s Stelara®, was approved in Japan as induction therapy for moderate to severely active Crohn’s disease, where other treatments are ineffective.
The approval of the IV formulation comes 9 months after Samsung Bioepis’ subcutaneous ustekinumab (45 mg syringe) was approved in Japan (December 2025). It was subsequently launched in May 2026. Samsung Bioepis’ biosimilar ustekinumab is being commercialised in Japan by Nipro under the terms of a June 2025 agreement.
Samsung Bioepis’ IV formulation of ustekinumab closely follows Celltrion’s IV formulation of Steqeyma® (ustekinumab), which was approved in Japan in April 2026 and launched in August 2026. Steqeyma® (IV and SC) is indicated for psoriasis and psoriatic arthritis, with the IV formulation additionally approved for Crohn’s disease.
Other ustekinumab biosimilars launched in Japan include Alvotech/Fuji Pharma’s AVT04 (May 2024) and Biocon/Yoshindo’s Ustekinumab BS Subcutaneous Injection, (May 2025).