On September 2, 2025, Shanghai Henlius Biotech, Inc. and Organon announced that the FDA has approved BILDYOS® (denosumab-nxxp) and BILPREVDA® (denosumab-nxxp) as denosumab biosimilars to Prolia® and XGEVA®, respectively. Both biosimilars have been approved for all indications of their reference products.
BILDYOS® and BILPREVDA® are RANK ligand inhibitors used to treat conditions such as osteoporosis and cancer-related skeletal complications. According to the press release, both biosimilars were approved based on the review of clinical studies demonstrating no clinically meaningful differences to their reference products in terms of safety, purity, and potency.
As we previously reported, WYOST® and Jubbonti® recently launched as the first denosumab biosimilars in the United States.
Stay tuned to Big Molecule Watch as we continue to cover developments in the biosimilars industry.