Sandoz inks global deal for Samsung Bioepis’ Vedolizumab biosimilar

SWITZERLAND—Sandoz has signed an agreement with Samsung Bioepis to partner on up to five biosimilars, starting with SB36, a biosimilar version of Takeda’s Entyvio (vedolizumab).

The South Korea-based biosimilars specialist is currently developing this product to treat ulcerative colitis and Crohn’s disease.

Under the agreement, Switzerland-based Sandoz gains commercial rights to market the biosimilars worldwide, while Samsung Bioepis retains commercial rights in China, Hong Kong, Taiwan, Macau, and South Korea.

Samsung Bioepis will continue to handle development, manufacturing, and regulatory submissions for the biosimilars.

The companies did not disclose financial terms of the partnership.

Expanding portfolio and market opportunities

This deal builds on the existing partnership between the two companies and could expand Sandoz’s biosimilar portfolio to an “industry-leading” 32 assets.

The growing pipeline positions Sandoz to capture a significant share of the USD 320 billion biosimilar loss-of-exclusivity market over the next decade.

The companies first partnered in 2023, when Sandoz acquired commercial rights to Samsung Bioepis’ Pyzchiva (ustekinumab), a biosimilar of Johnson & Johnson’s Stelara.

Sandoz launched the product in Europe in July 2024 and in the United States in February 2025.

Three months ago, the partners also collaborated on Epysqli (eculizumab), Samsung’s biosimilar version of AstraZeneca’s Soliris.

Analyst Perspectives and Future Plans

Jefferies analysts credited Sandoz’s “commercial infrastructure” as a key factor in its ability to attract partners.

They noted that the Samsung Bioepis arrangement provides Sandoz with improved long-term visibility on both research and development productivity and future launch timing.

Samsung Bioepis announced plans to expand its biosimilar portfolio by 20 products by 2030 during the J.P. Morgan Healthcare Conference two months ago.

Beyond its Entyvio biosimilar, the company plans to develop biosimilar versions of Regeneron and Sanofi’s Dupixent, Johnson & Johnson’s Tremfya, Daiichi Sankyo and AstraZeneca’s Enhertu, Roche’s Ocrevus, and Eli Lilly’s Taltz.

Patent landscape and market entry

Takeda states that its regulatory protection for Entyvio extends into May 2026, though some of the drug’s patents expire in 2032, according to the company’s most recent annual report.

Takeda noted that any biosimilar seeking to launch before 2032 would need to address potential patent infringement issues and validity concerns, making the exact timing of biosimilar entry uncertain.

For the last three quarters of 2025, Takeda reported worldwide Entyvio sales increased by 7% to 744.5 billion Japanese yen (USD 4.98 billion), with U.S. sales accounting for 494.8 billion Japanese yen (USD 3.03 billion).