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

  * Wyost® (denosumab) and Jubbonti® (denosumab) approved by EC for all
    indications of denosumab reference medicines Xgeva® and Prolia®
  * EC approval based on robust development program confirming that biosimilar
    matches reference medicine in terms of safety, efficacy and quality
  * Approved for treatment of cancer-related bone disease and osteoporosis
    respectively

Basel, May 22, 2024 - Sandoz, the global leader in generic and biosimilar
medicines, today announced that the European Commission (EC) has granted
marketing authorization for Wyost®1 (denosumab) and Jubbonti®2 (denosumab), the
first and only biosimilar versions of reference medicines Xgeva®*3 and
Prolia®*4 in Europe.
Wyost® is approved for the treatment of cancer-related bone disease.1 Jubbonti®
is approved to treat osteoporosis.2 These are key biosimilar value drivers for
the company over the mid-term and their approval is a major step in advancing
the Sandoz growth strategy. We expect to launch from November 2025 onwards.
Claire D'Abreu-Hayling, Sandoz Chief Scientific Officer, said: "Primary and
secondary bone loss, as well as cancer-related bone events, represent an immense
disease burden for patients, the economy and society as a whole. The approval of
the first European denosumab biosimilars is a crucial recognition of the need
for increased access to these potentially life-changing medicines and
demonstrates our continued commitment to delivering more sustainable treatment
options for patients, in Europe and beyond."
Close to one quarter (4.2 million) of all newly reported cancer cases globally
occur in Europe and cancer is ranked as a leading cause of premature death among
those 30-69 years of age in most European countries.5 Nearly all types of cancer
can spread to the bone and cause pain and fractures, though cancers that often
metastasize in bones include breast and prostate.6
In Europe, 32 million people over 50 years were estimated to live with
osteoporosis in 2019 with the number of fractures per year set to increase by
almost 25% until 2034.7 Despite wide availability of treatments only a minority
of patients at high risk currently receive treatment, even after their first
fracture.8
About Wyost(®) and Jubbonti(®)
Wyost® and Jubbonti® have been developed to match the reference medicines. 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.
The EC approvals are based on robust development programs. Wyost and Jubbonti
have the same dosage form, route of administration, dosing regimen and
presentation as the respective reference medicines.
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
morbidity(1).
Jubbonti is indicated in Europe to treat osteoporosis in postmenopausal women
and in men at increased risk of fractures, of 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 fracture(2).
*Prolia® and Xgeva® are registered trademarks of Amgen Inc.
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 update or
revise any forward-looking statements, except as required by law.
References
1. European Medicines Agency (EMA). Wyost® (Denosumab): Prescribing
Information. Available from:
https://www.ema.europa.eu/en/medicines/human/EPAR/wyost (Last accessed: May 2024)
2. European Medicines Agency (EMA). Jubbonti ® (Denosumab): Prescribing

    Information. Available from:
    https://www.ema.europa.eu/en/medicines/human/EPAR/jubbonti (Last accessed:
    May 2024)

3. European Medicines Agency (EMA). Xgeva® (Denosumab): Prescribing

    Information. Available from:
    https://www.ema.europa.eu/en/documents/overview/xgeva-epar-medicine-
    overview_en.pdf (Last accessed: May 2024).

4. European Medicines Agency (EMA). Prolia(®) (Denosumab): Prescribing

    Information. Available from:
    https://www.ema.europa.eu/en/documents/overview/prolia-epar-summary-
    public_en.pdf (Last accessed: May 2024).

5. The Cancer Atlas. The Burden of Cancer. Available from:

    https://canceratlas.cancer.org/the-burden/the-burden-of-cancer/ (Last
    accessed: May 2024)

6. American Cancer Society. Bone Metastases. Available from:

    https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-
    cancer/bone-metastases.html (Last accessed: March 2024)

7. 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: May 2024)

8. International Osteoporosis Foundation. Facts and Statistics. Available from:

    https://www.osteoporosis.foundation/facts-statistics/epidemiology-of-
    osteoporosis-and-fragility-fractures  (Last accessed: May 2024)

About Sandoz
Sandoz (SIX: SDZ; OTCQX: SDZNY) is the global leader in generic and biosimilar
medicines, with a growth strategy driven by its Purpose: pioneering access for
patients. More than 20,000 people of more than 100 nationalities work together
to ensure 800 million patient treatments are provided annually by Sandoz,
generating substantial global healthcare savings and an even larger social
impact. Its leading portfolio of approximately 1,500 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 first
biosimilar in 2006.
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