Samsung Bioepis Launches Ustekinumab Biosimilar in Japan

South Korean biopharmaceutical company Samsung Bioepis has begun selling Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 in Japan, marking the first commercial launch of a product in the country under its partnership with Nipro Corporation. The launch coincides with the implementation of a price standard set by the National Health Insurance (NHI), which officially listed the medication on May 19, 2026. This biosimilar references Stelara (ustekinumab) and targets specific immune-mediated diseases.

Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) granted marketing authorisation for the injection in December 2025. The drug is designed as a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody intended to prevent the abnormal regulation of interleukin-12 (IL-12) and interleukin-23 (IL-23). These cytokines are central to the immune response, and their uncontrolled activity drives inflammation in certain chronic conditions.

The approval covers the treatment of plaque psoriasis and psoriatic arthritis. Because the active ingredient targets specific biological pathways rather than broadly suppressing the immune system, the therapy offers a targeted approach for patients managing these conditions. The product is available as a pre-filled syringe for subcutaneous injection.

The commercialisation in Japan follows a strategic partnership announced between the two companies in June 2025. Under this agreement, Samsung Bioepis and Nipro are collaborating on the development and distribution of multiple biosimilar candidates. The launch of the ustekinumab biosimilar serves as the initial milestone for this collaboration.

The product is already available under different brand names in other major markets, including the European Union, South Korea, the United Kingdom, and the United States. This global footprint indicates that Samsung Bioepis is positioning the drug to compete directly with the reference product, Stelara, which was originally developed by Johnson & Johnson.

For patients and providers in Japan, the entry of this biosimilar into the market introduces a new option within the existing therapeutic setting. The availability of a locally listed and price-standardized product could potentially alter prescribing patterns if clinical outcomes match the reference drug. While biosimilars are designed to be highly similar, the introduction of a new biological agent often requires careful monitoring of efficacy and safety profiles in the local population.

The partnership between Samsung Bioepis and Nipro Corporation aims to expand access to vital treatments for patients suffering from chronic inflammatory conditions. By leveraging their combined expertise, the companies hope to improve outcomes for individuals managing complex diseases. Samsung Bioepis and Nipro have also pursued similar collaborations to address unmet medical needs in specific patient populations.