On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner NIPRO Corporation. SB17 will be marketed in Japan as “Ustekinumab BS Subcutaneous Injection 45 mg “Nipro””.
SB17 was approved in Japan in December 2025 for the treatment of plaque psoriasis and psoriatic arthritis. The product is being commercialised in Japan by NIPRO under the terms of a June 2025 agreement.
Samsung Bioepis is one of a number of biosimilar competitors launching ustekinumab products in Japan, including Alvotech/Fuji Pharma (May 2024), Biocon/Yoshindo (May 2025), and Celltrion (July 2025).
The Japan launch forms part of Samsung Bioepis’ global launch plans, with Epyztek® (SB17) being the first ustekinumab biosimilar approved in South Korea in April 2024. SB17 has also been approved in Europe in April 2024 as Pyzchiva®, and a Pyzchiva® autoinjector was launched in May 2025 as the first commercially available biosimilar ustekinumab pre-filled pen in Europe. In the US, Pyzchiva® was approved in July 2024 and launched in February 2025, in PFS and vial forms. Under a development and commercialisation agreement with Sandoz entered in September 2023, Sandoz has the right to commercialise Pyzchiva® in Europe, Switzerland, the UK, the US and Brazil.