Sandoz has struck a deal with Samsung Bioepis to partner on up to five biosimilars, with the first being SB36, a copycat of Takeda’s Entyvio (vedolizumab), which is being developed by the South Korea-based biosimilars specialist.
Switzerland-based Sandoz gains the right to commercialize the biosimilars around the world, with Samsung Bioepis retaining commercial rights in China, Hong Kong, Taiwan, Macau and its home country.
Samsung Bioepis will continue to develop, manufacture and handle the regulatory submissions for the biosimilars. Financial terms of the partnership were not disclosed.
The deal, which builds on the existing partnership of the companies, has the potential to expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets, the company said in a release. The growing pipeline of products will allow Sandoz to capture a “significant share” of the $320 billion biosimilar loss-of-exclusivity market opportunity in the next decade, the company added.
The companies initially got together in 2023, with Sandoz gaining commercial rights to Samsung’s Pyzchiva (ustekinumab), which is a knockoff of Johnson & Johnson’s Stelara. Sandoz launched it in Europe in July 2024 and in the U.S. in February 2025. Three months ago, the companies also paired up on Epysqli (eculizumab), which is Samsung’s biosimilar version of AstraZeneca’s Soliris.
With the most recent agreement, analysts from Jefferies credited Sandoz’s “commercial infrastructure” as key to its ability to attract partners. They also noted that the Samsung Bioepis arrangement provides Sandoz with “improved long-term visibility on both R&D productivity and future launch cadence.”
Samsung Bioepis plans to expand its biosimilar portfolio by 20 products by 2030, the company said two months ago at the J.P. Morgan Healthcare Conference. In addition to its Entyvio copycat, the company said it will develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AZ’s Enhertu, Roche’s Ocrevus and Eli Lilly’s Taltz.
As for Samsung and Sandoz’s plan to sell their Entyvio knockoff, Takeda has said its regulatory protection on the ulcerative colitis and Crohn’s disease treatment extends into May 2026. But some patents on the drug expire in 2032, according to the company's most recent annual report (PDF).
“Any biosimilar that seeks to launch prior to 2032 would need to address potential infringement and/or the validity of all relevant patents and therefore the exact timing of biosimilar entry is uncertain,” the Japanese company explained in the report.
For the last three quarters of 2025, Takeda reported Entyvio worldwide sales were up by 7% at 744.5 billion Japanese yen ($4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen ($3.03 billion).