Shanghai Henlius Biotech, Inc. and Organon have announced that the U.S. Food and Drug Administration (FDA) has approved BILDYOS (denosumab-nxxp) and BILPREVDA (denosumab-nxxp), biosimilars to the well-known bone care treatments PROLIA and XGEVA, respectively. Both biosimilars are approved for all indications of their reference products.
BILDYOS is indicated for multiple osteoporosis-related conditions, including treatment of postmenopausal women and men at high risk of fractures, glucocorticoid-induced osteoporosis, and bone loss associated with certain cancer therapies. BILPREVDA is approved for preventing skeletal-related events in patients with multiple myeloma, bone metastases from solid tumors, giant cell tumor of bone, and hypercalcemia of malignancy.
Jon Martin, US Commercial Lead at Organon, highlighted that the approvals mark an important step toward expanding access to essential bone care therapies, especially for the growing aging population in the U.S. “Our goal with these biosimilars is to improve access and affordability across multiple therapeutic areas,” Martin said.
Both biosimilars come with safety considerations similar to the reference products, including risks of severe hypocalcemia and hypersensitivity reactions. Patients with advanced kidney disease require careful monitoring when treated with BILDYOS, while BILPREVDA carries warnings for osteonecrosis of the jaw and fetal harm.
Dr. Jason Zhu, CEO of Henlius, emphasized that the FDA approvals reflect the company’s commitment to scientific excellence and delivering high-quality biosimilars. “We are proud to expand access to safe and effective biologic treatments through our collaboration with Organon,” Zhu said.
The approvals were based on extensive data demonstrating that BILDYOS and BILPREVDA have no clinically meaningful differences compared to PROLIA and XGEVA in terms of safety, purity, and potency.
Henlius and Organon entered a license and supply agreement in 2022, granting Organon exclusive commercialization rights to these biosimilars outside of China. Ping Cao, Chief Business Development Officer at Henlius, described the approvals as a testament to the strong partnership aimed at broadening patient access to affordable treatment options.
With these approvals, BILDYOS and BILPREVDA join Organon’s expanding biosimilars portfolio in the U.S., reinforcing the company’s commitment to advancing women’s health and delivering cost-effective therapies across major therapeutic areas.