Samsung Bioepis and Sandoz are starting a global license, development, and commercialization agreement for up to five biosimilar candidates.

These candidates, developed by Samsung Bioepis, include SB36, currently in pre-clinical development, referencing Takeda Pharmaceuticals’ Entyvio (vedolizumab). Entyvio’s indications are for the treatment of adult patients with Crohn’s disease, ulcerative colitis, and pouchitis.

In this agreement, Samsung Bioepis will take responsibility for development, regulatory registration in key markets, and manufacturing. Meanwhile, Sandoz will handle commercialization in global markets—excluding China, Hong Kong, Taiwan, Macau, and the Republic of Korea.

Currently, the two companies are not revealing any further agreement terms.

Other Biosimilar Collaborations

Samsung Bioepis and Sandoz have previously partnered on other commercializations and launches. Pyzchiva (ustekinumab), referencing Johnson & Johnson’s Stelara, launched in Europe in July 2024 and the U.S. in February 2025. Indications for Pyzchiva include moderate to severe psoriasis, active psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Additionally, Samsung Bioepis and Sandoz signed a December 2025 commercialization agreement for Epysqli (eculizumab) in the Middle East and Africa. This biosimilar to Alexion Pharmaceuticals’ Soliris has indications for treatment of generalized myasthenia gravis, among other conditions.

Samsung Happy with Sandoz Pact

In a press release, Samsung Bioepis President and CEO Kyung-Ah Kim expressed satisfaction with the continuing partnership with Sandoz.

“The agreement is [significant] in improving access to biologic[s] for patients … with debilitating conditions, who have limited access,” Kim said. “We will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability.”

Samsung Bioepis, established in 2012, is a wholly owned subsidiary of Samsung Epis Holdings. The biopharmaceutical company is advancing a pipeline of biologic candidates in immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology.