2 September 2025 - Shanghai Henlius Biotech and Organon today announced the US FDA has approved Bildyos (denosumab-nxxp) injection 60 mg/mL and Bilprevda (denosumab-nxxp) injection 120 mg/1.7 mL, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively, for all indications of the reference products.

Bildyos and Bilprevda were approved based on the review of a comprehensive data package, which included structural and functional analytical data, clinical pharmacokinetic data, and a comparative clinical study demonstrating that Bildyos and Bilprevda are highly similar to and have no clinically meaningful differences to their reference products, Prolia and Xgeva, respectively, in terms of safety, purity, and potency.

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