Samsung Bioepis and Sandoz have entered into a global licensing, development, and commercialization agreement for up to five biosimilar candidates. This partnership underscores a strategic move to broaden patient access to advanced biological therapies worldwide through shared expertise.
Development and distribution roadmap The centerpiece of this collaboration is SB36, a biosimilar referencing Takeda Pharmaceuticals’ Entyvio (vedolizumab). Currently in pre-clinical development, this candidate targets debilitating conditions such as Crohn’s disease and ulcerative colitis.
Under the terms of the agreement:
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Samsung Bioepis: Will lead the development, regulatory registration in key markets, and manufacturing processes.
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Sandoz: Will spearhead commercialization efforts across global markets, excluding mainland China, Hong Kong, Taiwan, Macau, and South Korea.
A track record of successful synergy This new pact builds upon a history of successful commercial collaborations between the two companies, including:
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Pyzchiva: A biosimilar to Stelara, which saw successful launches in Europe (July 2024) and the U.S. (February 2025).
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Epysqli: A biosimilar referencing Soliris, with a commercialization agreement for the Middle East and Africa finalized in late 2025.
Leadership at Samsung Bioepis emphasized that the continuing alliance with Sandoz reflects their enduring commitment to strengthening their biosimilar pipeline and ensuring that essential biopharmaceuticals become more widely available to patients with limited treatment options.