On March 18, 2026, Samsung Bioepis and Sandoz announced a global license, development and commercialization agreement for up to five biosimilar candidates, with the first being SB36, a biosimilar referencing Takeda Entyvio (vedolizumab). The partnership positions them to capture a substantial share of the projected global biosimilar loss-of-exclusivity market.
Under the terms, Samsung Bioepis retains responsibility for development, manufacturing, regulatory registration and IP. Sandoz gains exclusive global commercialization rights except in China, Hong Kong, Taiwan, Macau and Korea.
Entyvio (vedolizumab) is a gut-selective integrin antagonist approved for Crohn disease, ulcerative colitis and pouchitis. The drug generated approximately 6 billion dollars in global sales in 2025, making it one of the highest-revenue gastroenterology biologics worldwide.
The IBD market continues to expand, driven by increasing disease prevalence, improved diagnosis and growing biologic adoption.
SB36 is currently in preclinical development. Vedolizumab biosimilar development presents several technical challenges:
The partnership creates multi-layered opportunities across the biopharmaceutical supply chain including CHO cell line development, Protein A chromatography resins, GMP-grade excipients and analytical reference standards.
Market analysts project vedolizumab biosimilars could capture 30 to 50 percent of the reference product market within two years. The global biosimilar market is projected to exceed 100 billion dollars by 2030.
