• The agreement covers up to five assets, including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), for collaboration of development and commercialization in global markets excluding China, Hong Kong, Taiwan, Macau, and Republic of Korea
• Samsung Bioepis continues to pave the way for access to life-changing medicines by advancing a biosimilar pipeline across immunology and oncology

Samsung Bioepis Co., Ltd. announced today that the company has entered into a global license, development and commercialization agreement (DCA) with Sandoz for up to five biosimilar candidates under development by Samsung Bioepis, including SB36, a biosimilar candidate referencing Entyvio¹ (vedolizumab). The other terms of the agreement remain confidential.

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Samsung Bioepis office in Songdo, Incheon, Republic of Korea

Under the terms of the agreement, Samsung Bioepis will be responsible for development, regulatory registration in key markets, and manufacture of the biosimilars, while Sandoz will be responsible for commercialization in global markets, excluding China, Hong Kong, Taiwan, Macau, and Republic of Korea.

“We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.”

SB36, under pre-clinical development at Samsung Bioepis, references Entyvio (vedolizumab) which is indicated for the treatment of adult patients with Crohn’s disease, ulcerative colitis and pouchitis.²

The agreement builds on the global partnership between the two companies for PYZCHIVA^® (ustekinumab) established in September 2023. PYZCHIVA was first launched in Europe in July 2024 and in the United States in February 2025. In December 2025, the companies also signed an agreement for the commercialization of EPYSQLI™, a biosimilar to Soliris³ (eculizumab), for the Middle East and Africa region.

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. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit www.samsungbioepis.com and follow us on LinkedIn and X.

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