Sandoz launches denosumab biosimilars in Europe, providing affordable treatment option for cancer-related bone disease and osteoporosis for millions of patients

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

• Wyost^® (denosumab 120 mg) / Jubbonti^® (denosumab 60 mg) approved to treat cancer-related bone disease / osteoporosis across all indications of reference medicines
• Next milestone in Sandoz growth strategy; builds on 2025 launches of Wyost^® (denosumab) / Jubbonti^® (denosumab) and Tyruko^® (natalizumab) in US and Afqlir^® (aflibercept) in Europe
• Builds on established position in oncology and immunology
• Reinforces Sandoz commitment to helping patients access critical and potentially life-changing biologic medicines through leading global portfolio and pipeline 

Basel, December 1, 2025 – Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, today announced the European launch of Wyost^® (denosumab 120 mg) and Jubbonti^® (denosumab 60 mg). The medicines are among the first denosumab biosimilars to launch in Europe and are approved by the European Commission to treat all indications of the reference medicines, Xgeva^®* (denosumab 120 mg) and Prolia^®* (denosumab 60 mg)^1,2. Wyost^® is approved for the treatment of cancer-related bone disease¹ and Jubbonti^® is approved to treat osteoporosis².

Wyost^® and Jubbonti^® represent key value drivers for Sandoz and the European launch marks the next major step in advancing the company’s growth strategy. It builds on other key biosimilar launches this year including Wyost^® and Jubbonti^® in the US and the recent launches of Tyruko^® (natalizumab) in the US and Afqlir^® (aflibercept) in Europe.

Christophe Delenta, President Europe, Sandoz, said: “We know that primary and secondary bone loss, and cancer-related bone events, place a significant burden on millions of patients and their families, as well as on European healthcare systems. That’s why the launch of these denosumab biosimilars is such an important milestone, expanding access to these potentially life-changing medicines and reinforcing our commitment to delivering sustainable treatment options for patients.”

Close to one quarter (4.14 million)³ of all newly reported cancer cases globally occur in Europe and cancer remains a leading cause of premature death for people aged 30-69 years in most European countries⁴. Nearly all types of cancer can spread to the bone and cause pain and fractures, but cancers that often metastasize there include breast, lung and prostate⁵.

According to the latest figures, 32 million people in Europe over 50 years old are estimated to live with osteoporosis, with the number of fractures per year set to increase by almost 25% by 2034⁶. Only a minority of patients at high risk currently receive treatment, even after their first fracture⁷.

Wyost^® and Jubbonti^® will be launched across Europe today, with additional rollouts to follow throughout 2026. This launch builds on the continuing Sandoz leadership and pioneering legacy in biosimilars, dating back to the introduction of the first biosimilar in 2006. It further expands the company’s presence in a global reference-medicine market worth a combined ~USD 6.6 billion⁸ and reinforces its established position in oncology and immunology.  

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 13 biosimilars and a further 27 assets in various stages of development.

*Xgeva^® and Prolia^® are registered trademarks of Amgen Inc.

ABOUT WYOST^® (DENONSUMAB) AND JUBBONTI^® (DENOSUMAB)

Wyost^® (denosumab 120 mg) and Jubbonti^® (denosumab 60 mg) have been developed as biosimilars to the reference medicines Xgeva and Prolia, respectively^1,2. Both medicines contain the same active ingredient (denosumab), a human monoclonal antibody (IgG2) that targets and binds with high affinity and specificity to RANKL, preventing activation of its receptor, RANK, on the surface of osteoclast precursors and osteoclasts. Prevention of the RANKL/RANK interaction inhibits osteoclast formation, function and survival, thereby decreasing bone resorption in cortical and trabecular bone.

Wyost^® is indicated in Europe to prevent skeletal related events (SREs; pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone, and to treat adults and skeletally mature adolescents with a giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity¹.

Jubbonti^® is indicated in Europe to treat osteoporosis in postmenopausal women and in men at increased risk of fractures, bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures and bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture².

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 European Medicines Agency (EMA). Wyost (denosumab): Prescribing Information.
Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/wyost [Last accessed: November 2025].

² European Medicines Agency (EMA). Jubbonti (denosumab): Prescribing Information. Available at: https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti [Last accessed: November 2025].

³ Elmadani, M., Mokaya, P.O., Omer, A.A.A. et al. Cancer burden in Europe: a systematic analysis of the GLOBOCAN database (2022). BMC Cancer 25, 447 (2025). Available from: https://doi.org/10.1186/s12885-025-13862-1 [Last accessed: November 2025].

⁴ The Cancer Atlas. The Burden of Cancer. Available from: https://canceratlas.cancer.org/burden-of-cancer/ [Last accessed: November 2025].

⁵ American Cancer Society. Bone Metastases. Available from: https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/bone-metastases.html [Last accessed: November 2025].

⁶ International Osteoporosis Foundation. SCOPE ’21. ScoreCard for OsteoPorosis in Europe. Available from: https://www.osteoporosis.foundation/sites/iofbonehealth/files/2022-01/Slide%20set%20-%20EU%20general.pdf [Last accessed: November 2025].

⁷ International Osteoporosis Foundation. Facts and Statistics. Available from: https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-osteoporosis-and-fragility-fractures [Last accessed: November 2025].

⁸ Amgen. Letter to Shareholders and Annual Report. Available from: 2024 Annual Report Letter and 10-K. [Last accessed: November 2025].

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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