FDA Approves Bildyos and Bilprevda Biosimilars for Bone Cancer Care

The U.S. Food and Drug Administration has approved Bildyos (denosumab-nxxp) injection 60 milligrams per milliliter (mg/mL) as a biosimilar to Prolia (denosumab) and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 mL as a biosimilar to Xgeva (denosumab), with both approved for all indications of their reference products, according to a news release from Henlius.

“The FDA approvals of Bildyos and Bilprevda mark a significant step toward expanding access to critical bone care treatments needed by millions of people in the U.S., including a growing aging population,” Jon Martin, U.S. Commercial Lead, Biosimilars and General Medicines at Organon, said in the news release. “Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women.”

Bildyos and Bilprevda were approved after studies showed they are highly similar to their reference medicines, Prolia and Xgeva, with no meaningful differences in safety, quality or effectiveness. In 2022, Henlius partnered with Organon to bring these and other biosimilars to patients worldwide, with China as the exception.

Bildyos is a RANK ligand (RANKL) inhibitor used to treat osteoporosis in postmenopausal women and men at high risk for fracture, glucocorticoid-induced osteoporosis, bone loss in men on androgen deprivation therapy for prostate cancer, and bone loss in women on aromatase inhibitor therapy for breast cancer.

Patients with advanced kidney disease taking Bildyos may have a higher risk of severe low calcium levels. In some cases, this has led to hospitalization, life-threatening complications, and even death with denosumab medicines. Having chronic kidney disease–mineral bone disorder (CKD-MBD) can raise this risk even more. Before starting Bildyos, patients with advanced kidney disease should be checked for CKD-MBD, and treatment should be managed by a specialist experienced in this condition.

Bilprevda is a RANK ligand (RANKL) inhibitor used to prevent skeletal events in multiple myeloma and bone metastases, and to treat giant cell tumor of bone and hypercalcemia of malignancy unresponsive to bisphosphonates.

Some people may have allergic reactions to denosumab medicines like Bilprevda, including rare but serious reactions such as anaphylaxis. If this happens, treatment will be stopped. Bilprevda can also cause dangerously low calcium levels, which in some cases have been fatal. Low calcium should be corrected before starting treatment, and calcium and vitamin D supplements are needed during therapy. Calcium levels should be closely monitored, especially in the first few weeks.

Problems with the jawbone, called osteonecrosis of the jaw, have been reported. A dental exam is recommended before starting Bilprevda, and patients should avoid major dental work during treatment. Patients should also be checked if they develop thigh or groin pain, as this could signal a femur fracture. Stopping Bilprevda may increase the risk of spine fractures, so doctors will monitor closely. Bilprevda can also harm an unborn baby, so patients who can become pregnant should use effective birth control during treatment. See below for more safety information.

“These approvals are a testament to the strong collaboration between Henlius and Organon to expand patient access to quality and potentially more affordable biosimilars,” Ping Cao, chief business development officer and senior vice president of Henlius, said in the news release. “Together, we are working to broaden access to important treatment options and better meet the needs of both patients and providers in the U.S.”

Reference

1. “US Food and Drug Administration (FDA) Approves Henlius and Organon’s BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), Biosimilars to PROLIA (denosumab) and XGEVA (denosumab), Respectively,” Henlius. News Release. Sep. 2.

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