Sandoz Receives FDA Approval for First Denosumab Biosimilars in US and Canada

Sandoz查看公司主页 announced that the US Food and Drug Administration (FDA) approved Jubbonti查看药品详情 (denosumab查看药品详情-bddz) and Wyost查看药品详情 (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查看公司主页's reference medicines for all indications. Jubbonti查看药品详情 serves as the biosimilar to Prolia查看药品详情 for osteoporosis (搜索)搜索该疾病 treatment, while Wyost查看药品详情 corresponds to Xgeva查看药品详情 for preventing cancer-related bone complications.

Clinical Significance and Patient Impact

Osteoporosis (搜索)搜索该疾病 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查看公司主页 has achieved the first FDA approval for biosimilars to denosumab查看药品详情, a medicine that can address primary and secondary bone loss, such as osteoporosis (搜索)搜索该疾病, 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查看药品详情 is a humanized monoclonal antibody that inhibits the receptor activator of nuclear factor kappa-B ligand (RANKL (搜索)搜索该靶点). The drug works by preventing the development of osteoclasts, which are cells responsible for breaking down bone tissue.

Jubbonti查看药品详情 is approved to treat postmenopausal women with osteoporosis (搜索)搜索该疾病 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查看药品详情 is approved to prevent skeletal-related events in patients with multiple myeloma (搜索)搜索该疾病 and bone metastases (搜索)搜索该疾病 from solid tumors, treat adults and skeletally mature adolescents with giant cell tumor of bone (搜索)搜索该疾病 that is unresectable or where surgical resection would result in severe morbidity, and treat hypercalcemia of malignancy (搜索)搜索该疾病 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查看药品详情 approval includes approval of Sandoz查看公司主页'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查看药品详情 will be available as a 60 mg/mL solution in single-use pre-filled syringe for subcutaneous injection, while Wyost查看药品详情 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查看公司主页 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.