FDA Approves Denosumab-bddz for Osteoporosis, Cancer-Related Skeletal Events

The US Food and Drug Administration (FDA) has announced the approval of denosumab-bddz (Wyost, Jubbonti), the first FDA-approved, interchangeable denosumab biosimilars, according to a press release.¹ The drugs are approved for all indications of the reference drug (Xgeva).

The decision was based on clinical studies demonstrating no clinically meaningful differences between the biosimilar and bio-originator. Both biosimilars have the same dosage form, dosing regimen, and route of administration as the reference product, a human monoclonal antibody developed to bind to the receptor activator of nuclear factor kappa-Β ligand (RANKL) protein.

About Wyost (denosumab-bbdz)

Denosumab-bddz 120 mg/1.7 mL (70 mg/mL) injection is approved to reduce the risk of skeletal-related events (SREs) in patients with multiple myeloma and for those with bone metastases from solid tumors, to treat adult patients with skeletally mature adolescents with giant cell tumor of bone which is unresectable or where surgical resection is likely to result in severe morbidity, and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

About Jubbonti (denosumab-bbdz)

The 60 mg/1 mL injection of the denosumab-bbdz is approved to treat postmenopausal women with osteoporosis who are at a high risk for fracture, to increase bone mass in men with osteoporosis who are at a high risk for fracture, and to increase bone mass in men at high risk for fracture who are being treated with androgen deprivation therapy for nonmetastatic prostate cancer. It is also approved to treat glucocorticoid-induced osteoporosis and to increase bone mass in women at high risk for fracture who are being treated with adjuvant aromatase inhibitor therapy for breast cancer.

“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 Sandoz North America, in a statement. “I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most."

References

1. ^{Sandoz International GmbH. Sandoz receives FDA approval for first and only denosumab biosimilars. GlobeNewswire News Room. March 5, 2024. Accessed March 5, 2024. https://www.globenewswire.com/news-release/2024/03/05/2840809/0/en/Sandoz-receives-FDA-approval-for-first-and-only-denosumab-biosimilars.html.}