Shanghai Henlius Biotech, Inc. and Organon  announced that the US Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) injection 60 mg/mL and BILPREVDA® (denosumab-nxxp) injection 120 mg/1.7 mL as biosimilars to Prolia® (denosumab) and Xgeva® (denosumab), respectively. Both medicines are approved for all indications of their reference products.

With these approvals, patients and providers in the United States will gain access to more affordable treatment options for multiple conditions where denosumab therapy is standard of care. These include postmenopausal osteoporosis, glucocorticoid-induced osteoporosis, bone loss in men receiving androgen deprivation therapy for prostate cancer, bone loss in women receiving aromatase inhibitors for breast cancer, as well as prevention of skeletal-related events in multiple myeloma and certain cancers with bone metastases.

Expanding access to bone care
“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,” said Jon Martin, US Commercial Lead, Biosimilars and General Medicines at Organon. “Our goal is to improve access and affordability across multiple therapeutic areas, particularly for osteoporosis, which disproportionately affects women.”

Dr. Jason Zhu, Executive Director and CEO of Henlius, added: “These approvals represent another milestone for Henlius’ self-developed and self-manufactured biosimilars in the US. Through our collaboration with Organon, we are committed to providing patients with safe, effective, and affordable biologic alternatives that meet the highest standards of quality.”

Clinical data supports similarity
The approvals were based on a comprehensive data package including structural and functional analyses, pharmacokinetic studies, and a comparative clinical trial. The results demonstrated that BILDYOS and BILPREVDA are highly similar to Prolia® and Xgeva® with no clinically meaningful differences in terms of safety, purity, and potency.

A growing biosimilar portfolio
The products join Organon’s expanding US biosimilars portfolio, reflecting the company’s ongoing commitment to affordability, sustainability, and advancing women’s health. Under a 2022 agreement, Henlius granted Organon exclusive global commercialization rights (excluding China) for several biosimilars, including BILDYOS and BILPREVDA.

Like all denosumab products, BILDYOS and BILPREVDA carry risks of severe hypocalcemia, particularly in patients with advanced kidney disease. Other risks include hypersensitivity reactions, osteonecrosis of the jaw, atypical femoral fractures, and serious infections. Prescribers are advised to correct hypocalcemia before initiating treatment and to monitor calcium and vitamin D levels throughout therapy.

By broadening treatment options for osteoporosis and cancer-related bone disease, the FDA approvals of BILDYOS and BILPREVDA provide clinicians and patients with greater choice, access, and value in bone health management.