Denosumab-bbdz (Wyost/Jubbonti) has received FDA approval and is the first and only biosimilar to denosumab (Prolia/Xgeva) available in the United States.1,2 Like the reference products, denosumab-bbdz has been approved under 2 brand names, which have different indications.2
Key Takeaways
- Denosumab-bbdz, developed Sandoz, receives FDA approval. It is the first biosimilar to denosumab (Prolia/Xgeva) available in the US with different brand names, Wyost and Jubbonti, each approved for specific indications.
- Both products have FDA interchangeability designations and can be substituted for the reference product at the pharmacy level, making them the ninth biosimilar to receive this designation.
- FDA approval was based on comprehensive data, and Jubbonti's approval includes Sandoz's Risk Evaluation and Mitigation Strategy (REMS) program, addressing the risk of severe hypocalcemia, especially in patients with advanced chronic kidney disease dependent on dialysis.
Wyost received approval for the following indications:
- To prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid tumors
- To treat adults and skeletally mature adolescents with giant cell tumors of bone that are unrescetable or where surgical rescection is likely to lead to severe morbidity
- To treat hypercalcemia of malignancy refractory to bisphosphonate therapy
Jubbonti received approval for the following indications:
- 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 receiving androgen deprivation therapy for nonmetastatic prostate cancer at high risk for fracture
- To increase bone mass in women reciving adjuvant aromatase inhibitor theray for breast cancer at high risk for fracture
Both products were approved with interchangeability designations and can be substituted for the reference product at the pharmacy level. Denosumab-bbdz is the ninth biosimilar to receive this designation.2
“Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients,” said Keren Haruvi, president of Sandoz North America, in a news release.1
READ MORE: From Vaccine Breakthroughs to Biosimilar Innovations: 2023 Drug Approval Recap
More than 10 million adults aged 50 years and older in the United States have osteoporosis, a leading cause of fractures in both postmenopausal women and older men. Half of all women older than 50 years of age will experience and osteoporotic fracture during their lifetime.
FDA approval was based on a comprehensive data package inclusive of study results that were presented in 2023 at the American Society of Clinical Oncology and the American Society for Bone and Mineral Research annual meetings.2 The Jubbonti approval is accompanised by an approval of Sandoz’s Jubbonti Risk Evaluation and Mitigation Strategy (REMS) program, “designed to inform prescribers and patients about the risk of severe hypocalcemia” associated with the drug, particularly in patients with advanced chronic kidney disease dependent on dialysis.1
Due to ongoing patent litigation, Sandoz did not comment on launch details, including anticipated timing.
READ MORE: Biosimilar Resource Center
References
