Samsung Bioepis Gains Marketing Approval In Japan For 130mg Intravenous Infusion Of Ustekinumab Biosimilar

• Indicated for an induction therapy for moderate-to-severe active Crohn’s disease where other treatments are ineffective
• Marks second marketing approval in Japan through partnership with NIPRO CORPORATION after Ustekinumab BS Subcutaneous Injection 45mg Syringes「NIPRO」

Samsung Bioepis Co., Ltd. today announced the marketing approval of Ustekinumab BS Intravenous Infusion 130mg 「NIPRO」, a biosimilar referencing Stelara¹ (ustekinumab), indicated for an induction therapy for moderate-to-severe active Crohn’s disease where other treatments are ineffective. This is a second product to be approved in Japan under partnership with NIPRO CORPORATION (“NIPRO”).

"For patients living with autoimmune diseases, having access to a broader range of treatment options can make an important difference,” said Byoungin Jung, Vice President and Regulatory Affairs Team Leader at Samsung Bioepis. “Through our continued partnership with NIPRO, we are pleased to further expand access to quality-assured biosimilar treatment options for patients in Japan.”

Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that binds to the p40 subunit shared by IL-12 and IL-23, blocking their activity in immune-mediated diseases. Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has granted marketing authorization to Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」² in December 2025 which was subsequently launched in May 2026.

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

Samsung Bioepis’s ustekinumab biosimilar is also available under different brand names across the European Union (EU), Republic of 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 LinkedIn and X.

¹ Stelara is a trademark of Johnson & Johnson.

² Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 is indicated for the treatment of plaque psoriasis, psoriatic arthritis, and maintenance therapy for moderate-to-severe active Crohn's disease

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