INCHEON, KOREA -- Samsung Bioepis Co., Ltd. announced 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 Entyvio[1] (vedolizumab). The other terms of the agreement remain confidential.

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 Soliris[3] (eculizumab), for the Middle East and Africa region.