- Agreement clears path for launch of Jubbonti® and Wyost® on May 31, 2025 or earlier under certain circumstances
- Jubbonti® and Wyost® are first and only FDA-approved biosimilars to and interchangeable with Prolia*® and Xgeva*®
- Anticipated launch further strengthens Sandoz biosimilar portfolio and advances growth strategy
BASEL, Switzerland I April 30, 2024 I Sandoz, the global leader in generic and biosimilar medicines, today announced that it has reached agreement with Amgen to resolve all patent disputes between the two companies relating to the US Food and Drug Administration (FDA)-approved Sandoz denosumab biosimilars.
Patent infringement proceedings were initially filed by Amgen in the US Federal District Court for the District of New Jersey in May of 2023 pursuant to the Biologics Price Competition and Innovation Act (BPCIA). Resolution of the BPCIA litigation followed months of vigorous defense by Sandoz against claims by Amgen that the company infringed up to 21 patents expiring as late as 2037, protecting reference medicines Prolia® and Xgeva®. Under the terms of the agreement, Sandoz may enter the US market with a biosimilar version of Prolia® and Xgeva® on May 31, 2025, or earlier under certain circumstances if customary acceleration provisions are triggered.
Sandoz received FDA approval for the first and only denosumab biosimilars, Jubbonti® and Wyost®, on March 5, 2024. Jubbonti® and Wyost® are interchangeable with and approved by FDA for all indications of reference medicines Prolia® and Xgeva®. They have the same dosage form, route of administration, dosing regimen and presentation as the respective reference medicines.
The settlement clears the path to bring both Jubbonti® and Wyost® to the US market on May 31, 2025, or earlier under certain circumstances. Bringing denosumab to market allows us to further our Purpose of pioneering access for patients, by providing them with affordable high-quality medicines.
The terms of the agreement will not impact our previously disclosed 2024 guidance.
About Wyost® (denosumab-bbdz)
Wyost® is approved to prevent skeletal-related events (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.1
Bone is the third most frequent site for metastatic tumors.2 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.3
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).8,9 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.1
Please click to see full Prescribing Information for Wyost.
About Jubbonti® (denosumab-bbdz)
Jubbonti® is approved 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.4
Osteoporosis is a bone disease that develops when bone mineral density and bone mass decrease or when bone strength and structure change. People living with osteoporosis typically do not have symptoms and might not know they have the disease until they experience a fracture. More than 10 million US adults aged 50 and over live with osteoporosis, a major cause of fractures in postmenopausal women and in older men.5,6 Half of all women over the age of 50 will experience an osteoporotic fracture during their lifetime.7
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).8,9 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.4
Please click to see full Prescribing Information for Jubbonti.
References
1. Wyost®. Prescribing Information. Available at: Prescribing Information [Last accessed: March 2024]
2. Bone Metastasis. Apoorva Jayarangaiah; Alysia K. Kemp; Pramod Theetha Kariyann, Oct 25 2022. Available at https://www.ncbi.nlm.nih.gov/books/NBK507911/#:~:text=The%20skeleton%20is%20the%20third,metastasize%20to%20bone%20as%20well. [Last accessed: March 2024]
3. American Cancer Society. Bone Metastases. Available at: https://www.cancer.org/treatment/understanding-your-diagnosis/advanced-cancer/bone-metastases.html [Last accessed: March 2024]
4. Jubbonti®. Prescribing Information. Available at: Prescribing Information [Last accessed: March 2024]
5. National Institute of Arthritis and Musculoskeletal and Skin Diseases. Osteoporosis. 2022. Available at: https://www.niams.nih.gov/health-topics/osteoporosis [Last accessed: March 2024]
6. National Center for Health Statistics. Osteoporosis or Low Bone Mass in Older Adults: United States, 2017–2018. 2021. Available at: https://www.cdc.gov/nchs/products/databriefs/db405.htm [Last accessed: March 2024]
7. Bone Health and Osteoporosis Foundation. Osteoporosis Fast Facts. Available at: https://www.bonehealthandosteoporosis.org/wp-content/uploads/Osteoporosis-Fast-Facts-2.pdf [Last accessed: March 2024]
8. Amgen Inc. Prolia® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/Prolia/prolia_pi.pdf [Last accessed: March 2024]
9. Amgen Inc. Xgeva® (Denosumab): Prescribing Information. Available at: https://www.pi.amgen.com/-/media/Project/Amgen/Repository/pi-amgen-com/xgeva/xgeva_pi.pdf [Last accessed: March 2024]
*Xgeva® and Prolia® are registered trademarks of Amgen Inc.
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 800 million patient treatments are provided annually by Sandoz, generating substantial global healthcare savings and 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. In 2023, Sandoz recoded sales of 9.6 billion.
SOURCE: Sandoz
