FDA Approves Bildyos and Bilprevda, Biosimilars of Reference Denosumab

The FDA approved denosumab-nxxp injection 60 mg/mL (Bildyos) and denosumab-nxxp 120 mg/1.7 mL (Bilprevda; Shanghai Henlius Biotech, Organon), biosimilars to reference denosumab (Prolia, Xgeva; Amgen, respectively), for all indications. With this approval, Bildyos and Bilprevda have become additional cost-effective, more accessible options for patients who are unable to receive treatment with the reference product.¹

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Reference denosumab is a human monoclonal antibody that acts as a bone antiresorptive medication and is used to treat osteoporosis in women who have an increased risk for fractures following menopause (Prolia) and to prevent bone problems (eg, fracture, spinal cord compression, or the need for radiation/surgery to bone) in patients with multiple myeloma and bone metastases from tumors (Xgeva). With this action, Bildyos and Bilprevda join other notable biosimilars of denosumab, including denosumab-bmwo (Stoboclo; Celltrion), denosumab-bmwo (Osenvelt; Celltrion), denosumab-bnht (Conexxence, Bomyntra; Fresenius Kabi), denosumab-dssb 120-mg vial (Xbryk; Samsung Bioepis Co), and denosumab-dssb 60-mg prefilled syringe (Ospomyv; Samsung Bioepis Co), all of which are approved for all indications of the reference product.²

"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," said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. "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."¹

The manufacturers reported that this broad approval was based on a comprehensive data package, including structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that Bildyos and Bilprevda are highly similar to and have no clinically meaningful differences from their reference products, Prolia and Xgeva, respectively, in terms of safety, purity, and potency.¹

Specifically, Bildyos, which references Prolia, is indicated for the following¹:

• Treatment of postmenopausal women with osteoporosis at high risk for fracture.
• To increase bone mass in men with osteoporosis at high risk for fracture.
• Treatment of glucocorticoid-induced osteoporosis in men and women at high risk for fracture.
• To increase bone mass in men at high risk for fracture receiving androgen deprivation therapy for nonmetastatic prostate cancer.
• To increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Further, Bilprevda, which references Xgeva, is approved for the following¹:

• The prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors.
• The treatment of giant cell tumor of bone in adults and skeletally mature adolescents where surgical resection is unresectable or likely to result in severe morbidity.
• The treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy. Bilprevda is available as a 120 mg/1.7 mL injection.

It is important to note that a boxed warning regarding severe hypocalcemia in patients with advanced chronic kidney disease (CKD), including those on dialysis, may accompany Bildyos. Safety concerns for Bilprevda include hypersensitivity reactions, severe symptomatic hypocalcemia, osteonecrosis of the jaw, atypical subtrochanteric and diaphyseal femoral fractures, multiple vertebral fractures following treatment discontinuation, and embryo-fetal toxicity, emphasizing effective contraception for women of reproductive potential.¹

"We're proud to continue expanding access to quality biologics through the collaboration with Organon, delivering biosimilar treatment options that are as safe and effective as the reference biologics to more patients across the US,” Jason Zhu, MD, executive director and CEO of Henlius, in the news release.¹

REFERENCES

1. PR Newswire. 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. September 2, 2025. Accessed September 2, 2025. https://www.prnewswire.com/apac/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. McGovern G. LY01011, Biosimilar of Denosumab, Meets Primary End Point in Study. Pharmacy Times. August 26, 2025. Accessed September 2, 2025. https://www.pharmacytimes.com/view/ly01011-biosimilar-of-denosumab-meets-primary-end-point-in-study