FDA Approves Denosumab Biosimilars Across Multiple Indications

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Denosumab biosimilars have been approved by the FDA as Wyost and Jubbonti across various reference indications.

Wyost is approved to help prevent skeletal-related events for patients with multiple myeloma. Jubbonti is approved to treat women who are postmenopausal with osteoporosis and who may be at high risk for fracture.

Wyost is approved to help prevent skeletal-related events for patients with multiple myeloma. Jubbonti is approved to treat women who are postmenopausal with osteoporosis and who may be at high risk for fracture.

The FDA has approved denosumab-bbdz (Wyost) and denosumab-bbz (Jubbonti) to treat all indications of the previously referenced medicines, according to a press release from Sandoz.

Wyost is approved to help prevent skeletal-related events for patients with multiple myeloma. Additionally, it is designed to help with bone metastases for those with solid tumors and for adults and skeletally mature adolescents with giant cell tumors of bone that may be unresectable or for which surgery could cause severe morbidity. It can also help to treat hypercalcemia.

Jubbonti is approved to treat women who are postmenopausal with osteoporosis and who may be at high risk for fracture. It can also help to increase bone mass in men with osteoporosis with a high risk of fracture and can treat glucocorticoid-induced osteoporosis for men and women. Additionally, Jubbonti can help to increase bone mass for men with nonmetastatic prostate cancer who are receiving androgen deprivation therapy and women who are receiving adjuvant aromatase inhibitor therapy for breast cancer.

Wyost injection is recommended to be given at 120 mg/1.7 mL (70 mg/mL). It has been approved to be interchangeable with the reference medicine. The press release highlighted hypocalcemia as a contraindication.

The safety information for Wyost recommends that patients should not receive other denosumab products at the same time. A warning is included for hypersensitivity or anaphylaxis, and hypocalcemia. Previous deaths have been reported with denosumab use.

The most common adverse effects (AEs) occurring in 25% or more of patients with bone metastases from solid tumors included fatigue/asthenia, hypophosphatemia, and nausea. For patients with multiple myeloma, the most common AEs of 10% or more were diarrhea, nausea, and anemia. For giant tumor cell of the bone, toxicity included arthralgia, headache, and nausea. For hypercalcemia, it included nausea, dyspnea, and decreased appetite.

The recommended dose of Jubbonti injection is 60 mg/1 mL. This has been approved as interchangeable with the reference medicine. The contraindications include hypocalcemia, pregnancy, and known sensitivity to denosumab products.

Patients previously diagnosed with hypocalcemia must have it corrected before starting therapy with Jubbonti. Patients should also be evaluated for chronic kidney disease and mineral bone disorder. Patients should discontinue if a clinically significant reaction occurs.

Some AEs with Jubbonti included postmenopausal osteoporosis, male osteoporosis, and bone loss due to hormone ablation for cancer.

Denosumab may cause fetal harm. For those with reproductive potential, contraception should occur for 5 or more months after the last use of Jubbonti.

Reference

Sandoz receives FDA approval for first and only denosumab biosimilars. News release. Sandoz. March 5, 2024. Accessed March 5, 2024. https://shorturl.at/iuF17

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