INCHEON, South Korea, May 20, 2026
Samsung Bioepis has announced the official launch of Ustekinumab BS 45 mg Syringe for S.C. Injection「NIPRO」 in Japan, marking the company’s first biosimilar product launch in the Japanese pharmaceutical market through its strategic partnership with NIPRO CORPORATION. The biosimilar references Stelara® (ustekinumab) and became commercially available following its inclusion under Japan’s National Health Insurance (NHI) Drug Price Standard, which officially took effect on May 20, 2026.
The launch represents a significant milestone in Samsung Bioepis’ global biosimilar expansion strategy and strengthens the company’s growing footprint across major international healthcare markets. Industry analysts believe the commercialization of the ustekinumab biosimilar in Japan could improve patient access to more affordable biologic therapies while supporting healthcare system sustainability amid rising demand for autoimmune disease treatments.
Samsung Bioepis Expands Global Biosimilar Presence
The newly launched biosimilar was approved by Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) for the treatment of plaque psoriasis and psoriatic arthritis, two chronic immune-mediated inflammatory diseases that significantly impact patient quality of life. Ustekinumab is a human monoclonal antibody targeting interleukin-12 (IL-12) and interleukin-23 (IL-23) pathways, which play major roles in inflammatory and autoimmune disease progression.
Biologic therapies such as ustekinumab have transformed treatment standards for autoimmune disorders over the past decade, but high treatment costs continue limiting patient access in many healthcare systems. Biosimilars are designed to provide highly similar clinical efficacy, safety, and quality compared with originator biologics while increasing affordability and expanding healthcare access.
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Samsung Bioepis stated that the Japan launch reflects the company’s commitment to improving global healthcare accessibility through high-quality biosimilar development. Company executives emphasized that collaboration with NIPRO is expected to strengthen long-term support for Japanese patients living with chronic autoimmune conditions while helping reduce healthcare cost burdens.
The launch also marks the first commercial milestone under the strategic biosimilar partnership established between Samsung Bioepis and NIPRO in June 2025 for development and commercialization of multiple biosimilar candidates within the Japanese market.
Japan Biosimilars Market Continues Rapid Growth
Japan has emerged as one of the most strategically important global biosimilar markets due to increasing healthcare expenditures, aging demographics, and growing demand for biologic therapies across immunology, oncology, and chronic inflammatory diseases. Government initiatives encouraging biosimilar adoption have accelerated market growth while creating opportunities for international biopharmaceutical companies expanding into Asia-Pacific healthcare markets.
Healthcare experts believe wider biosimilar utilization could help improve long-term treatment access for patients requiring expensive biologic therapies while supporting sustainability of national reimbursement systems. Autoimmune diseases such as psoriasis and psoriatic arthritis often require prolonged biologic treatment to manage inflammation, preserve mobility, and reduce disease progression.
Samsung Bioepis’ ustekinumab biosimilar is already commercialized in several major global markets under different brand names, including PYZCHIVA™ in the United States, European Union, and United Kingdom, as well as EPYZTEK™ in South Korea. The Japanese launch further strengthens the company’s position within the competitive global biosimilars sector.
Biosimilars Drive Future Biopharma Competition
The biosimilars industry continues evolving rapidly as pharmaceutical companies target high-value biologic therapies approaching patent expiration. Analysts project strong long-term growth for biosimilars across immunology, oncology, endocrinology, hematology, and ophthalmology as healthcare systems increasingly prioritize cost-effective biologic treatment alternatives.
Founded in 2012, Samsung Bioepis has developed a broad biosimilar pipeline spanning multiple therapeutic categories including immunology, oncology, nephrology, neurology, endocrinology, and ophthalmology. The company has become one of the leading global biosimilar developers through ongoing investment in biologics manufacturing, regulatory science, and international commercialization partnerships.
Industry experts believe Japan will continue playing a critical role in future biosimilar market expansion due to increasing biologic therapy demand and supportive healthcare policy frameworks. Samsung Bioepis’ first Japanese biosimilar launch highlights growing momentum within the Asia-Pacific biopharmaceutical sector and underscores the expanding role of biosimilars in improving healthcare accessibility worldwide.
Source: Samsung Bioepis press release
