Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada
Key Insights
Sandoz received FDA approval for Jubbonti and Wyost, the first and only denosumab biosimilars approved in the United States and Canada, marking a significant milestone in biosimilar development.
The biosimilars are approved as interchangeable with Amgen's reference medicines Prolia and Xgeva for all indications, including osteoporosis (search) treatment and prevention of cancer-related bone complications.
More than 10 million US adults aged 50 and over live with osteoporosis (search), with half of all women over 50 experiencing an osteoporotic fracture during their lifetime.
Sandoz announced that the US Food and Drug Administration (FDA) approved Jubbonti (denosumab-bddz) and Wyost (denosumab-bddz) on March 5, 2024, marking the first and only FDA-approved denosumab biosimilars. Health Canada had previously granted marketing authorization for these products on February 20 and March 4, 2024, respectively.
The biosimilars are approved as interchangeable with Amgen's reference medicines for all indications. Jubbonti serves as the biosimilar to Prolia for osteoporosis (search) treatment, while Wyost corresponds to Xgeva for preventing cancer-related bone complications.
Clinical Significance and Patient Impact
Osteoporosis (search) represents a major public health challenge, affecting more than 10 million US adults aged 50 and over. The disease typically presents without symptoms until fractures occur, with half of all women over age 50 experiencing an osteoporotic fracture during their lifetime.
"Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis (search), as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients," said Keren Haruvi, President Sandoz North America.
Mechanism of Action and Indications
Denosumab is a humanized monoclonal antibody that inhibits the receptor activator of nuclear factor kappa-B ligand (RANKL (search)). The drug works by preventing the development of osteoclasts, which are cells responsible for breaking down bone tissue.
Jubbonti is approved to treat postmenopausal women with osteoporosis (search) at high risk for fracture, increase bone mass in men with osteoporosis at high risk for fracture, treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture, increase bone mass in men receiving androgen deprivation therapy for nonmetastatic prostate cancer, and increase bone mass in women receiving adjuvant aromatase inhibitor therapy for breast cancer.
Wyost is approved to prevent skeletal-related events in patients with multiple myeloma (search) and bone metastases (search) from solid tumors, treat adults and skeletally mature adolescents with giant cell tumor of bone (search) that is unresectable or where surgical resection would result in severe morbidity, and treat hypercalcemia of malignancy (search) refractory to bisphosphonate therapy.
Clinical Development and Safety Profile
The FDA approval is based on robust clinical studies including phase I and phase III trials, accompanied by labeling with safety warnings. The Jubbonti approval includes approval of Sandoz's Jubbonti Risk Evaluation and Mitigation Strategy (REMS) program, designed to inform prescribers and patients about the risk of severe hypocalcemia in patients with advanced chronic kidney disease.
Both biosimilars maintain the same dosage form, route of administration, dosing regimen, and presentation as their respective reference medicines. Jubbonti will be available as a 60 mg/mL solution in single-use pre-filled syringe for subcutaneous injection, while Wyost will be available in 120 mg/1.7 mL (70 mg/mL) solution delivered as a subcutaneous injection every four weeks.
Market Context
Bone represents the third most frequent site for metastatic tumors, with nearly all types of cancer capable of spreading to bone and causing pain and fractures. Breast and prostate cancers are among those that frequently metastasize to bones.
These approvals mark Sandoz Canada's eighth approved biosimilars and Sandoz US's seventh biosimilar approval. The company has not commented on anticipated launch timing due to ongoing patent litigation around these products.