The US Food and Drug Administration has approved BILDYOS and BILPREVDA, biosimilar versions of Amgen’s PROLIA and XGEVA bone treatment drugs, developed by Shanghai Henlius Biotech and commercialized by Organon across the United States.
BILDYOS (denosumab-nxxp) treats osteoporosis in postmenopausal women and men, glucocorticoid-induced osteoporosis, and bone loss in cancer patients receiving hormone-suppressing therapies. BILPREVDA (denosumab-nxxp) prevents bone complications in cancer patients with bone metastases and treats giant cell tumor of bone.
The approvals mark significant expansion in bone health treatment access, particularly for women who face disproportionately higher osteoporosis rates. Osteoporosis affects millions across the United States, with postmenopausal women representing the largest patient population for these medications.
“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 with these biosimilars is to improve access and affordability across multiple therapeutic areas, including for osteoporosis, which disproportionately affects women.”
Both biosimilars received approval based on comprehensive data demonstrating they are highly similar to their reference products with no clinically meaningful differences in safety, purity, and potency. The approval package included structural and functional analytical data, clinical pharmacokinetic data, and comparative clinical studies.
Henlius and Organon entered their licensing agreement in 2022, granting Organon exclusive global commercialization rights except for China. The partnership represents Henlius’s continued expansion into the US biosimilar market with self-developed and manufactured products.
“The FDA approvals of BILDYOS and BILPREVDA mark another set of Henlius’ self-developed and self-manufactured biosimilars approved in the United States, underscoring our commitment to scientific excellence and consistent product quality,” said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius.
The biosimilars join Organon’s growing US portfolio spanning five therapeutic areas over eight years. For women’s health specifically, BILDYOS addresses bone loss in breast cancer patients receiving aromatase inhibitor therapy, while BILPREVDA treats bone complications from metastatic disease.
