Samsung Bioepis Announces Approval of Ustekinumab Biosimilar in Japan

Company Overview - Samsung Bioepis Co., Ltd. has received marketing approval for Ustekinumab BS Subcutaneous Injection 45mg Syringes 'NIPRO', a biosimilar referencing Stelara, marking a significant milestone in its partnership with NIPRO CORPORATION established in June 2025 [1][2] - The company aims to provide accessible healthcare through innovations in product development and a commitment to quality, with a broad pipeline of biosimilar candidates across various therapeutic areas [4] Industry Context - Japan allocates approximately 10% of its GDP to healthcare, one of the highest rates among OECD countries, highlighting the increasing importance of biosimilars in reducing financial burdens on the healthcare system [2] - The approval of Ustekinumab BS is expected to expand access to high-quality, affordable treatment options for patients with autoimmune conditions, such as plaque psoriasis and psoriatic arthritis [2] Product Details - Ustekinumab is a human immunoglobulin G1 kappa (IgG1) monoclonal antibody that targets IL-12 and IL-23, which are associated with immune-mediated diseases [2] - The product is set to be included in Japan's National Health Insurance drug list in May 2026, allowing for immediate commercialization by NIPRO following the listing [2] Global Presence - Samsung Bioepis's Ustekinumab is already approved and available in multiple regions, including Australia, Brazil, Canada, Europe, Korea, Switzerland, the United Kingdom, and the United States [3]