Eculizumab-AAGH

Sandoz has inked a deal with Korean biosimilars specialist Samsung Bioepis to commercialize up to five copycats, including a knockoff of Takeda's Entyvio. 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).

The agreement covers up to five assets, including SB36, a biosimilar candidate referencing Entyvio (vedolizumab), for collaboration of development and commercialization in global markets excluding China, Hong Kong, Taiwan, Macau, and Republic of Korea Samsung Bioepis continues to pave the way for access to life-changing medicines by advancing a biosimilar pipeline across immunology and oncology INCHEON, Korea--(BUSINESS WIRE)-- #Entyvio --Samsung Bioepis Co., Ltd. announced today that the company has entered into a global license, development and commercialization agreement (DCA) with Sandoz for up to five biosimilar candidates under development by Samsung Bioepis, including SB36, a biosimilar candidate referencing Entyvio 1 (vedolizumab). The other terms of the agreement remain confidential. Under the terms of the agreement, Samsung Bioepis will be responsible for development, regulatory registration in key markets, and manufacture of the biosimilars, while Sandoz will be responsible for commercialization in global markets, excluding China, Hong Kong, Taiwan, Macau, and Republic of Korea. “We are very pleased to expand our successful partnership with Sandoz and to secure commercialization agreement for multiple biosimilar assets that are in early-stage development. The agreement is a significant progress in improving access to biologic medicines for patients living with debilitating conditions, who have limited access to life-changing medicines,” said Kyung-Ah Kim, President and Chief Executive Officer, Samsung Bioepis. “At Samsung Bioepis, we will continue to demonstrate our enduring commitment to biosimilars by further strengthening our pipeline and widening their availability for patients and healthcare systems across the world.” SB36, under pre-clinical development at Samsung Bioepis, references Entyvio (vedolizumab) which is indicated for the treatment of adult patients with Crohn’s disease, ulcerative colitis and pouchitis. 2 The agreement builds on the global partnership between the two companies for PYZCHIVA ® (ustekinumab) established in September 2023. PYZCHIVA was first launched in Europe in July 2024 and in the United States in February 2025. In December 2025, the companies also signed an agreement for the commercialization of EPYSQLI™, a biosimilar to Soliris 3 (eculizumab), for the Middle East and Africa region. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology. For more information, please visit and follow us on LinkedIn and X . 1 Entyvio is a registered trademark of Takeda Pharmaceuticals 2 European Medicines Agency (EMA). Entyvio. Summary of Product Characteristics. Available at: Entyvio, INN-vedolizumab . Last accessed March 2026 3 Soliris is a registered trademark of Alexion Pharmaceuticals Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com