FDA Approves Biosimilars for Prolia, Xgeva

The FDA approved denosumab-nxxp (Bildyos) injection 60 mg/mL and denosumab-nxxp (Bilprevda) injection 120 mg/1.7 mL as biosimilars to denosumab (Prolia) and denosumab (Xgeva), respectively, for all indications.¹

The FDA approves denosumab-nxxp (Bildyos and Bilprevda), enhancing access to vital bone health treatments for osteoporosis and cancer-related conditions. | Image Credit: sunnychicka - stock.adobe.com

"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 US, including a growing aging population. Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women," Jon Martin, US commercial lead of biosimilars and general medicines at Organon, said in a news release.¹ "This approval underscores Organon's unwavering commitment to making treatments more accessible while focusing on creating a more sustainable future for the care of bone health."

The approval of the drugs was based on comprehensive data, including pharmacokinetic data and a comparative clinical study of the drug. The data showed that both biosimilars are highly similar and have no clinically meaningful differences from their respective reference products, including for safety, purity, and potency.¹

For Bilprevda, the safety and efficacy of denosumab were examined for the prevention of skeletal-related events for patients with bone metastases from solid tumors in 3 trials comparing the drug to zoledronic acid. In the 3 studies, the overall survival and progression-free survival were similar, according to the prescribing information. Similarly for multiple myeloma, investigators also found that denosumab was noninferior to zoledronic acid.²

As for adverse reactions, hypersensitivity, hypocalcemia both with and following treatment, osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femur fracture, and multiple vertebral fractures following treatment discontinuation were seen.²

Likewise, Bildyos reduced the incidence of new morphometric vertebral fractures at 1, 2, and 3 years compared with the placebo for the treatment of postmenopausal osteoporosis as well as having lower hip fractures and nonvertebral fractures. For men with osteoporosis, investigators reported that treatment with denosumab increased bone mineral density at 1 year for the lumbar spine, total hip, and femoral neck, according to the results. Furthermore, investigators reported that denosumab significantly increased lumbar spine BMD at 1 year for patients with glucocorticoid-induced osteoporosis.³

Adverse reactions for Bildyos included severe hypocalcemia and mineral metabolism changes, hypersensitivity, osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures, multiple vertebral fractures following discontinuation, serious infections, and dermatologic adverse reactions.³

Bildyos is indicated for treatment of osteoporosis for women who are postmenopausal at high risk for fracture; to increase bone mass for men with osteoporosis at high risk for fracture; for treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture; to increase bone mass in men at risk for fracture and receiving androgen deprivation therapy for nonmetastatic prostate cancer; and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.¹

Bilprevda is indicated for the prevention of skeletal-related events for patients with bone metastases from solid tumors, multiple myeloma, giant cell bone tumors, and hypercalcemic malignancy.¹

READ MORE: Biosimilar Resource Center

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REFERENCES

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. News release. Henlius. September 2, 2025. Accessed September 2, 2025. https://prnmedia.prnewswire.com/news-releases/us-food-and-drug-administration-fda-approves-henlius-and-organons-bildyos-denosumab-nxxp-and-bilprevda-denosumab-nxxp-biosimilars-to-prolia-denosumab-and-xgeva-denosumab-respectively-302543830.html

2. Bilprevda (denosumab-nxxp) injection [prescribing information]. Organon LLC; 2025. https://www.organon.com/product/usa/pi_circulars/b/bilprevda/bilprevda_pi.pdf. Accessed September 2, 2025.

3. Bildyos (denosumab-nxxp) injection [prescribing information]. Organon LLC; 2025. https://www.organon.com/product/usa/pi_circulars/b/bildyos/bildyos_pi.pdf. Accessed September 2, 2025.