Sandoz signs global license agreement to commercialize breast cancer biosimilar pertuzumab

• Agreement with EirGenix Inc. grants Sandoz exclusive rights to commercialize proposed biosimilar of pertuzumab for treatment of HER2-positive early breast cancer / metastatic breast cancer
• Reference medicine market worth USD 4.1 billion in global sales
• Pertuzumab used in combination with other therapies, highly complementary to proposed Sandoz biosimilars trastuzumab and trastuzumab deruxtecan
• Strengthens overall Sandoz position in oncology and reinforces ongoing commitment to expand patient access to affordable medicines and drive sustainable savings for healthcare systems 

Basel, November 12, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the signing of a global license agreement to commercialize a proposed biosimilar of oncology medicine pertuzumab.

The agreement with EirGenix Inc. (EirGenix Inc., 6589.TW) is milestone-based for a total consideration of up to USD 152 million, including an upfront payment and further potential incentives dependent upon market performance. The reference medicine market is worth an estimated USD 4.1 billion¹ in global sales, and pertuzumab will join the deep Sandoz pipeline with the strategic objective to capitalize on a projected ~USD 300 billion biosimilar market opportunity over the next 10 years².

Under the terms of the agreement, Sandoz has exclusive worldwide commercial rights to a biosimilar of pertuzumab, excluding certain countries in Asia*, while EirGenix Inc. will be responsible for development, manufacturing and supply. The medicine has already completed a human pharmacokinetic similarity clinical study.

Richard Saynor, CEO of Sandoz, said: “According to the latest estimates, up to 2.3 million patients worldwide are diagnosed with breast cancer each year and, of these cases, approximately 15% to 20% are HER2-positive breast cancer³.

“This agreement underscores our commitment to expand patient access, as well as support healthcare systems by offering high quality and more affordable treatment options. It also enhances our biosimilar oncology portfolio and complements our pipeline, given that the combination of pertuzumab and trastuzumab represents the standard of care in this field.”

The reference medicine Perjeta^®** is a humanized IgG1 monoclonal antibody that is used in combination with other therapies, including trastuzumab, to treat HER2-positive early breast cancer and HER2-positive metastatic or locally recurrent unresectable breast cancer^4,5.

The agreement strengthens the collaboration between Sandoz and EirGenix Inc, with an existing agreement already in place for worldwide commercialization*** of the proposed biosimilar trastuzumab, in both 150 mg and 420 mg forms. Studies also show that a combination of pertuzumab and trastuzumab deruxtecan could become a new first-line standard for HER2-positive metastatic breast cancer⁶, with a biosimilar of trastuzumab deruxtecan currently in the Sandoz pipeline.

Sandoz is committed to helping millions of patients access critical and potentially life-changing biologic medicines sustainably and affordably, with a leading global portfolio comprising 11 marketed biosimilars and a further 27 assets in various stages of development. The marketed biosimilar oncology portfolio includes Rixathon^®, Zarzio^®, Ziextenzo^® and Binocrit^®. Sandoz also launched Wyost^®/Jubbonti^® (denosumab) in the US in June 2025 and expects to launch in Europe in the fourth quarter of 2025.

* Countries out of scope: Taiwan, China, Macau, Korea, Mongolia, Brunei, Cambodia, Indonesia, Laos, Myanmar, the Philippines and Japan

** Perjeta^® is a registered trademark of Roche

*** Under this agreement, Sandoz holds the right to commercialize the medicine globally except in Russia, China, Taiwan, Australia, and some other Asian and South American 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 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 Evaluate Pharma, Summary: Worldwide Sales [Last accessed November 2025]

² Based on March 2025 data from IPD Analytics Evaluate Pharma, covering the period 2026–2035

³ World Cancer Research Fund, ‘Breast Cancer Statistics’. Available at: Breast cancer statistics | World Cancer Research Fund [Last accessed November 2025]

⁴ Perjeta^® Summary of Product Characteristics. Available at: Perjeta, INN-pertuzumab [Last accessed November 2025]

⁵ Perjeta^® Prescribing Information. Available at: PERJETA [Last accessed November 2025]

⁶ The trial DESTINY-Breast09 showed that Enhertu^® (trastuzumab deruxtecan) and pertuzumab significantly delayed cancer progression compared to the current standard of care (taxane and trastuzumab and pertuzumab)

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 people of 100 nationalities work together to ensure 900 million patient treatments are provided by Sandoz, generating substantial global healthcare savings and an even larger social impact. Its leading portfolio of approximately 1,300 products addresses diseases from the common cold to cancer. Headquartered in Basel, Switzerland, Sandoz traces its heritage back to 1886. Its history of breakthroughs includes Calcium Sandoz in 1929, the world’s first oral penicillin in 1951, and the world’s first biosimilar in 2006. In 2024, Sandoz recorded net sales of USD 10.4 billion.  

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