Shanghai Henlius Biotech, Inc. and Organon have jointly announced that the U.S. Food and Drug Administration (FDA) has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp). These are biosimilars to the reference products PROLIA and XGEVA, respectively. This approval is significant as it provides new, potentially more affordable, treatment options for multiple bone-related conditions. BILDYOS is a RANK ligand (RANKL) inhibitor indicated for several conditions, including the treatment of postmenopausal osteoporosis in women and men with osteoporosis, glucocorticoid-induced osteoporosis, and bone loss in men and women receiving certain cancer therapies. BILPREVDA, also a RANKL inhibitor, is indicated for preventing skeletal-related events in patients with multiple myeloma and bone metastases, among other conditions. The approvals are based on comprehensive data demonstrating that the biosimilars are highly similar to their reference products with no clinically meaningful differences in safety, purity, or potency.

The collaboration between Henlius, which developed and manufactured the biosimilars, and Organon, which holds the exclusive commercialization rights in most global markets outside of China, highlights a shared commitment to expanding access to quality biologics. According to Jon Martin from Organon, the goal is to improve access and affordability for millions of people in the U.S., particularly the aging population and women disproportionately affected by osteoporosis. Dr. Jason Zhu of Henlius echoed this sentiment, emphasizing the company's commitment to scientific excellence and consistent product quality. The approval of these two products further strengthens Organon's growing biosimilars portfolio, which has been expanding for over eight years and now spans five major therapeutic areas. This milestone reflects the companies’ commitment to creating a more sustainable and accessible future for bone health care.