Samsung Bioepis has entered a new global agreement with Sandoz to develop and commercialise up to five next‑generation biosimilar candidates, strengthening a partnership that has been expanding steadily in recent years.
Announced in Incheon, Korea, the deal includes SB36, a biosimilar referencing Entyvio (vedolizumab), and applies to global markets excluding China, Hong Kong, Taiwan, Macau and the Republic of Korea. Other terms of the agreement have not been disclosed.
Under the arrangement, Samsung Bioepis will lead development, regulatory registration in key markets and manufacturing, while Sandoz will take responsibility for commercialisation across the covered territories.
Kyung‑Ah Kim, President and Chief Executive Officer of Samsung Bioepis, said: “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.”
She added: “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 is currently in pre‑clinical development and references Entyvio, which is indicated for adult patients with Crohn’s disease, ulcerative colitis and pouchitis.
The latest agreement builds on a series of collaborations between the two companies. Their partnership for PYZCHIVA (ustekinumab) began in September 2023, with launches in Europe in July 2024 and the United States in February 2025. In December 2025, the companies also signed a deal covering the Middle East and Africa for EPYSQLI, a biosimilar to Soliris (eculizumab).
The new partnership signals Samsung Bioepis’ continued push to expand its biosimilar pipeline across immunology and oncology, aiming to increase global access to advanced therapies.
