Samsung Bioepis Launches Ustekinumab Biosimilar, Marking Its First Product Launch in Japan

• Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 is now available in Japan, after its listing under the National Health Insurance (NHI) Drug Price Standard
• Marks first launch in Japan through partnership with NIPRO CORPORATION
• Samsung Bioepis continues to expand its global presence, widening access to life-enhancing treatments for patients with chronic autoimmune conditions

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced the launch of Ustekinumab BS 45 mg Syringe for S.C. Injection「 NIPRO」, a biosimilar referencing Stelara¹ (ustekinumab), marking its first product launch in Japan under partnership with NIPRO CORPORATION (hereafter “NIPRO”). The launch follows the Official Gazette announcement on May 19 regarding the product’s listing under the National Health Insurance (NHI) Drug Price Standard, which became effective today.

"We are thrilled to announce the launch of our first biosimilar product in Japan in partnership with NIPRO,” said Jinhan Chung, Vice President and Head of Commercial Strategy for International Markets, at Samsung Bioepis. “Together with our partner NIPRO, we look forward to supporting patients living with autoimmune diseases and contributing to the sustainability of Japan's healthcare system by providing quality-assured, safe and effective biosimilar options.”

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. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted marketing authorization to Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 for the treatment of plaque psoriasis and psoriatic arthritis in December 2025.²

Samsung Bioepis announced a strategic partnership with NIPRO for the development and commercialization of multiple biosimilar candidates in Japan, including ustekinumab, in June 2025.

Samsung Bioepis’s ustekinumab biosimilar is also available under different brand names across the European Union (EU), Korea, the United Kingdom (UK), and the United States (US).³

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 biologic 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.

^1 Stelara is a trademark of Johnson & Johnson.

^2 Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 is not indicated for the treatment of Crohn's disease or ulcerative colitis.

^3 Samsung Bioepis’s ustekinumab biosimilar is available under the brand name PYZCHIVA™ in the EU, the UK, and the US. In Korea, it is available under the brand name EPYZTEK™.