Incheon, South Korea, September 3, 2026

Samsung Bioepis has announced that its ustekinumab biosimilar has received marketing approval in Japan for a 130 mg intravenous infusion formulation, expanding access to biologic treatment for patients with moderate-to-severe active Crohn’s disease. The approval covers Ustekinumab BS Intravenous Infusion 130mg 「NIPRO」, which references Stelara (ustekinumab) and is indicated for induction therapy in patients whose moderate-to-severe active Crohn’s disease has not responded adequately to other treatments. The authorization represents the second Samsung Bioepis product approved in Japan through its partnership with NIPRO CORPORATION, strengthening the companies’ efforts to broaden availability of quality-assured biosimilar medicines in the Japanese market.

Japan Approval Expands Ustekinumab Biosimilar Access

The newly approved product provides an intravenous formulation of ustekinumab, a biologic medicine used in immune-mediated diseases. Ustekinumab is a human IgG1 kappa monoclonal antibody that binds to the p40 subunit shared by interleukin-12 (IL-12) and interleukin-23 (IL-23), thereby blocking signaling pathways involved in inflammatory and immune responses. In Japan, the newly approved intravenous formulation is intended for the induction phase of treatment for moderate-to-severe active Crohn’s disease when other treatments are ineffective. The approval therefore adds another biosimilar option within an important therapeutic area where long-term biologic treatment can represent a substantial component of patient care. The Japanese authorization also builds on Samsung Bioepis’ earlier progress with ustekinumab biosimilars in the country. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) previously granted marketing authorization in December 2025 for Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」, which was subsequently launched in May 2026. That product is indicated for conditions including plaque psoriasis, psoriatic arthritis, and maintenance therapy for moderate-to-severe active Crohn’s disease. The latest intravenous approval extends the partnership’s product offering and provides a formulation specifically relevant to induction therapy.

Samsung Bioepis and NIPRO Expand Biosimilar Partnership

The approval follows a strategic partnership between Samsung Bioepis and NIPRO established in June 2025 for the development and commercialization of multiple biosimilar candidates in Japan, including ustekinumab. Under the collaboration, the companies are working to increase patient access to biologic therapies while leveraging biosimilar development to expand treatment options. Samsung Bioepis said the latest approval demonstrates continued progress in the partnership and contributes to its broader objective of providing quality-assured biosimilar medicines to patients. The ustekinumab biosimilar also has a broader international presence. Samsung Bioepis reports that its ustekinumab biosimilar is available under different brand names across the European Union, United Kingdom, United States and Republic of Korea. In the EU, UK and US, the product is marketed under the PYZCHIVA brand, while it is available as EPYZTEK in Korea. The expanding geographic availability highlights the growing role of biosimilars in improving access to established biologic therapies across multiple healthcare systems.

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Broader Impact on Biologic Treatment and Biosimilar Adoption

The Japanese approval adds to Samsung Bioepis’ growing portfolio of biosimilar products across immunology, oncology, ophthalmology, hematology, nephrology, neurology and endocrinology. By introducing an approved intravenous ustekinumab biosimilar option for Crohn’s disease induction, the company is contributing to the diversification of biologic treatment choices in Japan. The development also illustrates how biosimilar regulatory approvals and commercial partnerships can support broader access to established biologic medicines while maintaining the scientific and quality requirements expected of biological products.

Source: Samsung Bioepis press release