Sandoz announces strategic collaboration with Henlius on up to 10 biosimilars, further expanding industry-leading pipeline

Ad hoc announcement pursuant to art. 53 SIX Swiss Exchange Listing Rules

MEDIA RELEASE
 

• Agreement for up to 10 biosimilar assets represents one of largest ever biosimilar collaborations for Sandoz

• Expands industry-leading pipeline to 39 assets¹ with potential to increase to up to 46, strengthening leading position in biosimilars

• Initial agreement covers biosimilars of cetuximab, evolocumab and belimumab, and option for recombinant human hyaluronidase

• Reinforces commitment to expand patient access by capturing significant share of unprecedented biosimilar loss-of-exclusivity market opportunity over next decade
   

Basel, 17 August 2026 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announces a major development, manufacturing and commercialisation collaboration agreement with Shanghai Henlius Biotech, Inc. (Henlius, HKEX:02696), marking another significant step to broaden patient access to high-quality biosimilar medicines worldwide.

The agreement paves the way for the two companies to collaborate on up to 10 biosimilars, with an initial bundle of assets already agreed. Under its terms, Sandoz will have global commercialisation rights for agreed biosimilar assets outside China, while Henlius will be responsible for development and manufacturing. The collaboration agreement is milestones-based for a total consideration of up to USD 322 million, with near-term payments associated with the initial assets that could reach up to USD 100.5 million.

Richard Saynor, Chief Executive Officer, Sandoz, says: “Expanding access to life-enhancing medicines for patients around the world lies at the heart of everything we do. By strengthening our collaboration with Henlius through this strategic agreement, one of our largest ever in biosimilars, we are not only underlining our commitment to patients but also taking another step towards capturing a significant share of the unprecedented biosimilar market opportunity that lies ahead.”

One of the initial assets under the agreement will be a proposed cetuximab biosimilar, which is in clinical development. The reference medicine, Erbitux^®* (cetuximab), is an epidermal growth factor receptor-targeted oncology therapy used to treat selected patients with metastatic colorectal cancer and squamous cell carcinoma of the head and neck^{2, 3}. Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death worldwide⁴. According to the latest estimates, close to one million new cases of head and neck cancer are reported annually⁵.

In addition, the collaboration also covers a proposed evolocumab biosimilar used in patients with hypercholesterolaemia and for reducing the risk of major cardiovascular events in adults at increased cardiovascular risk⁶, and a proposed belimumab biosimilar intended for the treatment of active systemic lupus erythematosus in adults and children and active lupus nephritis in eligible patients, in addition to standard therapy⁷.Finally, there is an option for a recombinant human hyaluronidase to be used in the development of a subcutaneously administered biosimilar, which increases the dispersion and absorption of other injected medicines. The proposed evolocumab biosimilar and recombinant human hyaluronidase are in technical development, while belimumab is in early development.

Overall, the collaboration expands the industry-leading Sandoz biosimilar pipeline to 39 assets¹, with the potential to increase to up to 46, and represents another milestone in the Company’s strategy to capitalise on a significant share of the unprecedented global biosimilar loss-of-exclusivity market over the next decade. It also builds on the existing collaboration between the two companies, first established in April 2025 through a global collaboration agreement for oncology therapy ipilimumab.

Sandoz continues to expand its industry-leading pipeline of biosimilar medicines, building on its experience as the pioneer and global leader with a portfolio of 13 molecules available in nearly 100 countries.

*Erbitux^® is a registered trademark of ImClone LLC.
 

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 materialise 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 Reflects agreement with Samsung Bioepis for up to five biosimilar assets, including vedolizumab

² European Medicines Agency. Erbitux^® (cetuximab): EPAR product information. Available at: EMA Erbitux product information. [Last accessed August 2026]

³ U.S. Food and Drug Administration (FDA). Erbitux^® (cetuximab). Prescribing Information. Available at: Erbitux® (cetuximab) US Prescribing Information. [Last accessed August 2026]

⁴ Wu, S., Zhang, Y., Lin, Z. et al. Global burden of colorectal cancer in 2022 and projections to 2050: incidence and mortality estimates from GLOBOCAN. BMC Cancer 25, 1770 (2025). Available at: https://doi.org/10.1186/s12885-025-15138-0 [Last accessed August 2026]

⁵ Sun H, Yu M, An Z, Liang F, Sun B, Liu Y and Zhang S (2025) Global burden of head and neck cancer: Epidemiological transitions, inequities, and projections to 2050. Front. Oncol. 15:1665019. Available at: https://doi.org/10.3389/fonc.2025.1665019. [Last accessed August 2026]

⁶ European Medicines Agency. Repatha^® (evolocumab): EPAR product information. Available at: EMA Repatha product information. U.S. Food and Drug Administration. Repatha^® (evolocumab): Prescribing Information. Available at: FDA Repatha prescribing information. [Last accessed August 2026]

⁷ European Medicines Agency. Benlysta^® (belimumab): EPAR product information. Available at: EMA Benlysta product information. U.S. Food and Drug Administration. Benlysta^® (belimumab): Prescribing Information. Available at: FDA Benlysta prescribing information. [Last accessed August 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.