Samsung Bioepis Secures Japanese Approval for Ustekinumab Biosimilar, Expands Global Autoimmune Treatment Access
Key Insights
Samsung Bioepis (search) received Japanese regulatory approval for its ustekinumab biosimilar, marking the company's first partnership with a Japanese firm to enter Japan's biopharmaceutical market.
The biosimilar will launch in Japan in May 2025 under partnership with Nipro (search), targeting a global Stelara market estimated at $10.36 billion.
Samsung Bioepis (search) also reached a settlement agreement with Johnson & Johnson for European commercialization of PYZCHIVA, its ustekinumab biosimilar approved by the European Commission in April 2024.
Samsung Bioepis (search) has achieved significant regulatory milestones for its ustekinumab biosimilar across multiple markets, securing Japanese approval and finalizing European commercialization agreements that promise to expand patient access to critical autoimmune treatments.
Japanese Market Entry Through Strategic Partnership
Samsung Bioepis (search) announced it received approval from Japanese regulators to sell its biosimilar treatment for autoimmune disease (search), marking the company's first business partnership with a Japanese company to enter Japan's biopharmaceutical market. The biosimilar, which references Johnson & Johnson's original drug Stelara, was approved under the product name Ustekinumab BS Subcutaneous Injection 45mg Syringes Nipro.
The product will launch in the Japanese market in May 2025 under a partnership with Japanese medical equipment manufacturer Nipro (search). "Japan allocates about 10 percent of its gross domestic product to healthcare, one of the highest levels among Organization for Economic Cooperation and Development countries," said Jung Byoung-jin, vice president of Samsung Bioepis (search). "As a result, biosimilars are playing an increasingly important role in easing the financial burden on the country's healthcare system."
European Settlement Enables Market Access
Samsung Bioepis (search) has also signed a settlement and license agreement with Johnson & Johnson concerning the commercialization of PYZCHIVA, its biosimilar to Stelara (ustekinumab), in Europe. The terms of the agreement remain confidential, but the settlement clears the path for continued European market presence.
PYZCHIVA was approved as a biosimilar to Stelara by the European Commission in April 2024 and launched by Sandoz in Europe in July 2024. The biosimilar became available in pre-filled pen (autoinjector) format in May 2025, providing additional administration options for patients.
Therapeutic Applications and Market Impact
Ustekinumab is a human immunoglobulin G1 kappa (IgG1κ) monoclonal antibody that prevents abnormal regulation of IL-12 (search) and IL-23 (search) associated with immune-mediated diseases. PYZCHIVA is currently approved for the treatment of adults and pediatric patients from the age of 6 years and older with moderate to severe plaque psoriasis (search), adults with active psoriatic arthritis (search), and adults with moderate to severely active Crohn's disease (search).
The global market for Stelara is estimated at 15 trillion won ($10.36 billion), according to data from Johnson & Johnson cited by Samsung Bioepis (search). The same biosimilar is marketed under different names across regions: Epyztek (search) in Korea, Pyzchiva in Europe and the United States, and will be known as Ustekinumab BS Subcutaneous Injection 45mg Syringes Nipro in Japan.
Commitment to Healthcare Accessibility
"This is a significant milestone for patients living with autoimmune diseases as we are making a step forward in improving access to this important biologic medicine for healthcare systems, providers, and patients," said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, Samsung Bioepis (search). "With unwavering commitment to quality, we will continue our efforts to make our medicines more accessible so that more patients can receive the treatment they need."
Samsung Bioepis (search), established in 2012, continues to advance a broad pipeline of biosimilar candidates covering therapeutic areas including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. The company's strategic partnerships and regulatory successes across major markets position it to deliver on its mission of making healthcare accessible to everyone.