Henlius and Organon Receive FDA Approval for Denosumab Biosimilars
Wednesday, September 03, 2025
Shanghai Henlius Biotech and Organon have received approval from the US Food and Drug Administration (FDA) for BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp), biosimilars to Prolia and Xgeva.
BILDYOS, supplied as a 60 mg/mL injection, is indicated for the treatment of postmenopausal women and men with osteoporosis at high risk of fracture, patients with glucocorticoid-induced osteoporosis, and individuals receiving therapies that increase fracture risk, such as androgen deprivation therapy for prostate cancer or aromatase inhibitor therapy for breast cancer.
The approvals cover all existing indications of the reference medicines, expanding treatment options for patients in the United States.
BILDYOS, supplied as a 60 mg/mL injection, is indicated for the treatment of postmenopausal women and men with osteoporosis at high risk of fracture, patients with glucocorticoid-induced osteoporosis, and individuals receiving therapies that increase fracture risk, such as androgen deprivation therapy for prostate cancer or aromatase inhibitor therapy for breast cancer.
BILPREVDA, supplied as a 120 mg/1.7 mL injection, is indicated for the prevention of skeletal-related events in certain patients with multiple myeloma and bone metastases from solid tumours. It is also approved for use in patients with giant cell tumour of bone and hypercalcaemia of malignancy.
The approvals were supported by a comprehensive data package including structural, functional, and pharmacokinetic studies, as well as comparative clinical trials. These showed that the biosimilars are highly similar to their reference medicines, with no clinically meaningful differences in terms of safety, purity, or potency.
Both products carry important safety considerations. Patients with advanced kidney disease receiving BILDYOS face a higher risk of severe hypocalcaemia and should be evaluated for chronic kidney disease-mineral bone disorder before starting treatment. In the case of BILPREVDA, risks include severe hypocalcaemia, hypersensitivity reactions, osteonecrosis of the jaw, and foetal harm. Patients should be monitored carefully during therapy, with calcium and vitamin D supplementation recommended.
Henlius and Organon have been working together under a licence and supply agreement signed in 2022, which granted Organon exclusive rights to commercialise BILDYOS and BILPREVDA outside China.
The two companies highlighted that the approvals expand treatment options for patients in the US while contributing to broader access to biologic therapies.
Source: henlius.com
