Friday, March 20, 2026

Sandoz partners with Samsung Bioepis on up to five biosimilars

Sandoz has entered a license, development and commercialization agreement with Samsung Bioepis. The companies say the partnership is intended to broaden access to biosimilar medicines globally.

Up to five assets, starting with vedolizumab

The agreement covers collaboration on up to five biosimilar assets. The first program is planned to be a vedolizumab biosimilar that is in early-stage development. The reference medicine is Entyvio (vedolizumab), which is used in adult patients with Crohn’s disease, ulcerative colitis or pouchitis.

Commercial scope and division of work

Sandoz will hold exclusive commercialization rights globally, except in China, Hong Kong, Taiwan, Macau and the Republic of Korea. Samsung Bioepis will be responsible for development, manufacturing and regulatory submissions in key markets. The parties did not disclose financial terms.

Pipeline impact and market context

Sandoz said the collaboration could expand its biosimilar pipeline to up to 32 assets. The company also pointed to a projected global biosimilar loss-of-exclusivity opportunity of around USD 320 billion over the next decade.

Building on existing collaboration

Sandoz and Samsung Bioepis have worked together since 2023, when they set up a global partnership for Pyzchiva (ustekinumab). Sandoz launched Pyzchiva in Europe in July 2024 and in the US in February 2025. The companies stated that this collaboration is not affected by the newly announced agreement. In December 2025, they also signed a deal covering commercialization of Epysqli, an eculizumab biosimilar to Soliris, for the Middle East and Africa region.

Company background

Sandoz highlighted its biosimilar portfolio of 13 molecules available in close to 100 countries as the basis for further pipeline expansion.