Sandoz and Henlius Partner to Advance Biosimilars in Oncology, Cardiovascular and Immunology

Sandoz and Henlius Partner to Advance Biosimilars in Oncology, Cardiovascular and Immunology

(IN BRIEF) Sandoz has announced a major strategic collaboration with Shanghai Henlius Biotech, Inc. covering up to 10 biosimilar assets, in one of the largest biosimilar collaborations in Sandoz’s history. Under the agreement, Sandoz will receive global commercialisation rights outside China for agreed assets, while Henlius will handle development and manufacturing, with milestone-based consideration of up to USD 322 million and near-term payments for the initial assets potentially reaching USD 100.5 million. The initial collaboration covers proposed biosimilars of cetuximab, evolocumab and belimumab, as well as an option for recombinant human hyaluronidase, expanding Sandoz’s biosimilar pipeline to 39 assets with potential to reach up to 46. The agreement builds on the companies’ existing collaboration for ipilimumab and supports Sandoz’s strategy to strengthen its biosimilars position and increase patient access to affordable medicines amid a significant expected global biosimilar loss-of-exclusivity opportunity over the next decade.

(PRESS RELEASE) BASEL, 18-Aug-2026 — /EuropaWire/ — Sandoz has announced a major development, manufacturing and commercialisation collaboration agreement with Shanghai Henlius Biotech, Inc., known as Henlius, covering up to 10 biosimilar assets.

The agreement represents one of the largest biosimilar collaborations ever entered into by Sandoz and marks another step in the company’s strategy to expand access to high-quality, affordable biosimilar medicines worldwide.

Under the terms of the agreement, Sandoz will hold global commercialisation rights outside China for the agreed biosimilar assets, while Henlius will be responsible for development and manufacturing.

The collaboration is milestone-based, with total potential consideration of up to USD 322 million.

Near-term payments linked to the initial assets could reach up to USD 100.5 million.

The initial agreement covers proposed biosimilars of cetuximab, evolocumab and belimumab, as well as an option for recombinant human hyaluronidase.

The collaboration expands Sandoz’s industry-leading biosimilar pipeline to 39 assets, with the potential to increase to as many as 46 assets.

Sandoz said the agreement strengthens its position in biosimilars and supports its ambition to capture a significant share of the expected global biosimilar loss-of-exclusivity opportunity over the next decade.

Richard Saynor, Chief Executive Officer of Sandoz, said expanding access to life-enhancing medicines for patients around the world is central to the company’s work.

He said the strategic collaboration with Henlius, one of Sandoz’s largest ever in biosimilars, reinforces the company’s commitment to patients and represents another step toward participating in the major biosimilar market opportunity ahead.

One of the initial assets under the agreement is a proposed cetuximab biosimilar currently in clinical development.

The reference medicine, Erbitux® or 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.

Colorectal cancer is the third most commonly diagnosed cancer and the second leading cause of cancer death worldwide.

According to recent estimates cited by Sandoz, nearly one million new cases of head and neck cancer are reported each year.

The collaboration also includes a proposed evolocumab biosimilar.

Evolocumab is used in patients with hypercholesterolaemia and to reduce the risk of major cardiovascular events in adults at increased cardiovascular risk.

The agreement also covers a proposed belimumab biosimilar intended for the treatment of active systemic lupus erythematosus in adults and children, as well as active lupus nephritis in eligible patients, in addition to standard therapy.

In addition, Sandoz has an option for recombinant human hyaluronidase, which may be used in the development of a subcutaneously administered biosimilar by increasing the dispersion and absorption of other injected medicines.

The proposed evolocumab biosimilar and recombinant human hyaluronidase are in technical development.

The proposed belimumab biosimilar is in early development.

The agreement builds on the existing collaboration between Sandoz and Henlius, first established in April 2025 through a global collaboration agreement for the oncology therapy ipilimumab.

Sandoz said it continues to expand its biosimilar pipeline, building on its experience as a pioneer and global leader in the field.

The company currently has a portfolio of 13 biosimilar molecules available in nearly 100 countries.

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.
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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.

SOURCE: Sandoz