Sandoz has announced a major license, development and commercialisation partnership agreement with Samsung Bioepis, marking a significant step to broaden patient access to high-quality biosimilar medicines worldwide.
The agreement paves the way for the two companies to partner on up to five biosimilar assets. The first asset will be a vedolizumab biosimilar, which is in early-stage development.
Under the terms of the agreement, Sandoz will have exclusive rights to commercialise globally, except in China, Hong Kong, Taiwan, Macau and Republic of Korea. Samsung Bioepis will be responsible for development, regulatory submissions in key markets and manufacturing.
The partnership could expand the leading Sandoz pipeline to up to 32 assets and reinforces its commitment to capturing a significant share of the projected global biosimilar loss-of-exclusivity market opportunity, estimated at around USD 320 billion over the next decade.
The news builds on the successful global partnership between the two companies first established in September 2023 for Pyzchiva® (ustekinumab), which Sandoz launched in Europe in July 2024 and in the US in February 2025.
Richard Saynor, Chief Executive Officer, Sandoz, said: “This partnership underscores our unwavering commitment to expanding access to affordable, high-quality medicines for patients worldwide. It is another important step toward capitalising on the unprecedented biosimilar market opportunity over the next decade while also strengthening our partnership with Samsung Bioepis.”
