Samsung Bioepis Announces Approval of Ustekinumab Biosimilar in Japan

• Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO' has been granted marketing approval in Japan

• First marketing approval under the partnership with NIPRO CORPORATION, paving the way for expanding treatment option for patients in Japan

• ‘NIPRO’ will be commercially available following its listing on the National Health Insurance (NHI) drug price list in May 2026

Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', a biosimilar referencing Stelara1 (ustekinumab), developed by Samsung Bioepis. This is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025.

“Japan allocates about 10% of its GDP to healthcare2, one of the highest among OECD countries which is why biosimilars are playing an increasingly important role in alleviating the financial burden for Japan’s healthcare system. With this biosimilar approval, we are paving the way for expanding access to high-quality, affordable treatment options for patients with autoimmune conditions,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “As a proven biosimilar leader, we remain committed to delivering quality-assured biologics that support better care for patients and strengthen healthcare systems around the world.”

Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 and IL-23 associated with immune-mediated diseases. ‘NIPRO’ has been approved for the treatment of plaque psoriasis, and psoriatic arthritis. The product is set to be listed in the Japan’s National Health Insurance (NHI) drug list in May 2026, allowing for commercialization by NIPRO immediately after drug listing.

Samsung Bioepis’s ustekinumab is also approved and available across Australia, Brazil, Canada, Europe, Korea, Switzerland, the United Kingdom, and the United States.

About Samsung Bioepis Co., Ltd.

Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit www.samsungbioepis.com and follow us on social media – X, LinkedIn.