BASEL, Switzerland I June 2, 2025 I
Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in generic and biosimilar medicines, has announced that WYOST® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are available to patients in the US starting today. WYOST® and Jubbonti® are the first and only interchangeable FDA-approved denosumab biosimilars and are approved to treat all indications of the reference medicines XGEVA®* (denosumab) and Prolia®* (denosumab), respectively.[2,3]
This launch builds on Sandoz established leadership in biosimilars and oncology, dating back to the introduction of the first biosimilar in the US in 2015. WYOST® and Jubbonti® are key biosimilar value drivers that are integral to the Sandoz growth strategy, representing a significant step forward in advancing the Company’s ambition to be the biosimilar leader in the US.
Keren Haruvi, President Sandoz North America, said: “Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients.”
WYOST® and Jubbonti® have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines. WYOST® and Jubbonti® are approved as interchangeable with the reference medicines for all indications. WYOST® and Jubbonti® will be launching with an established Q code.
Sandoz is providing comprehensive support resources for patients who are prescribed WYOST® and Jubbonti®, including reimbursement and financial support.
Claire Gill, Chief Executive Officer, Bone Health and Osteoporosis Foundation, said: “Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve.”
Bone metastases occur when cancer cells move away from the original tumor site and into the bone, weakening its structure and often causing significant skeletal-related events (SREs) such as pain and fractures.[4] They are most common in patients with breast, prostate, lung, kidney and thyroid cancers and approximately 330,000 people in the US are living with bone metastases.[4]
Osteoporosis is a condition that develops when bone mineral density and bone mass decrease causing the bones to become thinner, weaker and more likely to break.[5] Over 10 million US adults 50 years of age or older live with osteoporosis, with over 43 million at risk due to low bone mass.[1,5] Half of all women and a quarter of all men over the age of 50 will break a bone due to osteoporosis.[6]
*XGEVA® and Prolia® are registered trademarks of Amgen Inc.
About WYOST® (denosumab-bbdz)
WYOST® 120 mg/1.7 mL (70 mg/mL) injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[3,7] WYOST® is indicated in the US to prevent SREs in patients with multiple myeloma and in patients with bone metastases from solid tumors, to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.[7]
This is not the complete list of all the safety information for Wyost. Please click to see full
Prescribing Information
for Wyost.
About Jubbonti® (denosumab-bbdz)
Jubbonti® 60 mg/1 mL injection has been approved by the FDA as interchangeable with the reference medicine, a human monoclonal antibody designed to bind to the RANKL protein, an activator of osteoclasts (cells involved in breaking down bone tissue).[2,8] Jubbonti® is indicated in the US to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, to increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer, and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.[8]
This is not the complete list of all the safety information for Jubbonti. Please click to see full
Prescribing Information
for Jubbonti.
REFERENCES
[1] Sarafrazi N, Wambogo EA, Shepherd JA. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. Centers for Disease Control and Prevention. 2021;405. Available at:
https://www-cdc-gov.libproxy1.nus.edu.sg/nchs/products/databriefs/db405.htm
[Last accessed: June 2025]
[2] Food and Drug Administration. Prolia® (Ustekinumab): Medication Guide. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/125320s213lbl.pdf
[Last accessed: June 2025]
[3] Food and Drug Administration. XGEVA® (Ustekinumab): Medication Guide. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/125320s0000lbl.pdf
[Last accessed: June 2025]
[4] Moffitt Cancer Center. Bone Metastasis. Available at:
https://www.moffitt.org/cancers/bone-metastasis/
[Last accessed: June 2025]
[5] Food and Drug Administration. Osteoporosis. Available at:
https://www.fda.gov/consumers/womens-health-topics/osteoporosis
[Last accessed: June 2025]
[6] American Academy of Orthopaedic Surgeons. Osteoporosis. Available at:
https://orthoinfo.aaos.org/en/diseases–conditions/osteoporosis/
[Last accessed: June 2025]
[7] WYOST®. Prescribing Information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf
[Last accessed: June 2025]
[8] Jubbonti®. Prescribing Information. Available at:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/761362s000lbl.pdf
[Last accessed: June 2025]
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 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.
SOURCE:
Sandoz