FDA Approves Pair of Interchangeable Denosumab Biosimilars

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The FDA has approved a pair of interchangeable denosumab biosimilars developed by Sandoz—denosumab-bddz (Wyost) and denosumab-bddz (Jubbonti)—for use across all indications of the reference drug denosumab (Xgeva and Prolia), both manufactured by Amgen.¹ The denosumab biosimilars have the same dosage, route of administration, regimen, and presentation as the approved reference products.

"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 in North America, in a press release.¹

Because Wyost and Jubbonti were granted FDA interchangeability designations, pharmacists can substitute the biosimilars for the respective reference drug without needing to wait for a provider to obtain permission. This is the ninth biosimilar to receive the interchangeability label.

According to Sandoz, more than 10 million US adults over 50 years of age have osteoporosis, most of whom are women. A projected one in two women and one in four men are projected to experience an osteoporosis-related fracture during their lifetime.

Wyost is indicated as a 120 mg/1.7 mL injection to prevent skeletal-related events in patients with multiple myeloma and patients with bone metastases from solid tumors; for adult and skeletally mature adolescent patients with unresectable giant cell tumor of the bone for whom surgery is likely to result in severe morbidity; and for hypercalcemia of malignancy refractory to bisphosphonate therapy. The human monoclonal antibody was developed to attach to the RANKL protein, which activates cells that break down bone tissue.

Jubbonti is indicated to treat postmenopausal women with osteoporosis that has a high risk of fracture; to increase bone mass in men with osteoporosis who have an elevated risk of fracture; for glucocorticoid-induced osteoporosis in patients with a high risk of fracture; to increase bone mass in men with a high risk of fracture who are undergoing androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women with a high risk of fracture who are receiving adjuvant aromatase inhibitor therapy for breast cancer. The human monoclonal antibody is approved as a 60 mg/1 mL injection.¹

The FDA approval is accompanied by labeling regarding safety warnings. The approval of Jubbonti approval also includes an approval of a Risk Evaluation and Mitigation Strategy program regarding the risk of severe hypocalcemia associated with the drug in patients with advanced chronic kidney disease, including those dependent on dialysis.

Sandoz stated that because of ongoing litigation regarding the biosimilars, it did not have information on anticipated launching timing or other associated details at this time.¹

Sandoz filed the biologics license application for Wyost in February 2023.

“In addition to being an important medicine for cancer of the bone, denosumab is critical in the treatment of osteoporosis and potential prevention of osteoporosis-related fractures that so many women over 50 are at risk of,” Haruvi said in a prior press release.²

References

1. Sandoz receives FDA approval for first and only denosumab biosimilars. Sandoz. News release. March 5, 2024. Accessed March 5, 2024. https://finance.yahoo.com/news/sandoz-receives-fda-approval-first-182400066.html?guccounter=1&guce_referrer=aHR0cHM6Ly93d3cuZ29vZ2xlLmNvbS8&guce_referrer_sig=AQAAAHdqpfvto3WWE6N1GaDElMdRJwb5La7Zmkwp-wST5QHiUxbIW3GfnZySD8-ojN68aCQOy_FaBGWkZ6TyvlOOU5u4L6gITqiQvzGORb8CyHaIDekJqeSOsTbxokZ78MgwrARvXCTckbisyIaoFGA6tIGYKFBCpGnLrBcchX_mzWiG

2. Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA. Novartis. News release. February 6, 2023. Accessed March 5, 2024. https://www.novartis.com/news/media-releases/sandoz-biologics-license-application-proposed-biosimilar-denosumab-accepted-us-fda