Sandoz and Samsung Bioepis Expand Strategic Partnership to Advance Global Biosimilar Pipeline and Market Reach

Sandoz and Samsung Bioepis Expand Strategic Partnership to Advance Global Biosimilar Pipeline and Market Reach

(IN BRIEF) Sandoz has announced a new partnership with Samsung Bioepis to develop and commercialize up to five biosimilar medicines, beginning with a vedolizumab biosimilar targeting inflammatory bowel diseases. The agreement grants Sandoz global commercialization rights in most markets, while Samsung Bioepis will handle development and manufacturing. The collaboration builds on an existing partnership between the two companies and could expand Sandoz’s biosimilar pipeline to as many as 32 assets. It also aligns with Sandoz’s strategy to capture a significant portion of the projected USD 320 billion biosimilar market opportunity over the next decade, reinforcing its position as a global leader in affordable medicines.

(PRESS RELEASE) BASEL, 19-Mar-2025 — /EuropaWire/ — Sandoz (SIX:SDZ/OTCQX:SDZNY), a global leader in generic and biosimilar medicines, has entered into a new licensing, development, and commercialization agreement with Samsung Bioepis Co., Ltd., aimed at expanding access to biosimilar treatments worldwide. The collaboration marks a strategic move to strengthen both companies’ positions in the rapidly growing biosimilars market.

The agreement covers up to five biosimilar candidates, with the first project focusing on a biosimilar version of vedolizumab, currently in early development. The reference product, Entyvio®, is widely used in the treatment of inflammatory bowel diseases, including Crohn’s disease, ulcerative colitis, and pouchitis.

As part of the arrangement, Sandoz will hold exclusive global commercialization rights for the partnered biosimilars, with the exception of certain Asian markets including China, Hong Kong, Taiwan, Macau, and South Korea. Samsung Bioepis will lead development, regulatory filings in major markets, and manufacturing activities. Financial terms of the agreement have not been disclosed.

This collaboration has the potential to significantly expand Sandoz’s biosimilar pipeline, increasing it to as many as 32 assets. It also supports the company’s broader ambition to capture a meaningful share of the estimated USD 320 billion global opportunity arising from biosimilar loss-of-exclusivity over the coming decade.

Richard Saynor, Chief Executive Officer of Sandoz, highlighted the importance of the partnership in advancing access to cost-effective, high-quality treatments for patients globally. He noted that the agreement also builds on the companies’ existing relationship while positioning Sandoz to benefit from the significant growth expected in the biosimilars sector.

The latest partnership builds upon earlier collaborations between Sandoz and Samsung Bioepis. In 2023, the companies began working together on Pyzchiva® (ustekinumab), which has since been launched in Europe and the United States. That partnership remains unchanged. More recently, in December 2025, the companies agreed on the commercialization of Epysqli™, a biosimilar to eculizumab (Soliris®), targeting markets in the Middle East and Africa.

Sandoz continues to strengthen its biosimilar portfolio, drawing on its experience as a pioneer in the field. The company currently offers 13 biosimilar molecules across nearly 100 countries, reinforcing its role as a leading player in improving global access to advanced biologic therapies.

DISCLAIMER

This Media Release contains forward-looking statements, which offer no guarantee with regard to future performance. These statements are made on the basis of management’s views and assumptions regarding future events and business performance at the time the statements are made. They are subject to risks and uncertainties including, but not confined to, future global economic conditions, exchange rates, legal provisions, market conditions, activities by competitors and other factors outside of the control of Sandoz. Should one or more of these risks or uncertainties materialize or should underlying assumptions prove incorrect, actual outcomes may vary materially from those forecasted or expected. Each forward-looking statement speaks only as of the date of the particular statement, and Sandoz undertakes no obligation to publicly revise any forward-looking statements, except as required by law.

REFERENCES

¹ Covers US and EU markets (2026–2035). Originator sales and LoE based on internal analysis of data from multiple subscription databases. Biosimilar data accessed in September 2025.
² European Medicines Agency (EMA). Entyvio. Summary of Product Characteristics. Available at: Entyvio, INN-vedolizumab. [Last accessed March 2026]
³ FDA. Entyvio. Prescribing Information. Available at: ENTYVIO. [Last accessed March 2026]

ABOUT SANDOZ

Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in affordable medicines, with a growth strategy driven by its Purpose: pioneering access for patients. More than 20,000 colleagues of 100 nationalities work together to ensure over one billion patients are reached by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 medicines addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. In 2026, Sandoz celebrates 20 years of pioneering biosimilars, 80 years of antibiotics manufacturing and 140 years of heritage. In 2025, Sandoz recorded net sales of USD 11.1 billion.

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