SHANGHAI, China – NOVEMBER 11, 2025 – Shanghai Henlius Biotech, Inc. (2696.HK) today announced the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom has granted marketing authorization for BILDYOS® (denosumab) injection 60 mg/mL and BILPREVDA® (denosumab) injection 120 mg/1.7 mL, biosimilars to PROLIA (denosumab) and XGEVA (denosumab), respectively, for all indications of the reference products. 1,2
“The UK approvals are expected to further enhance the accessibility of denosumab biosimilars BILDYOS® and BILPREVDA®, offering new options for bone health management,” said Ping Cao, Chief Business Development Officer and Senior Vice President of Henlius. “Building on prior approvals in the U.S. and EU, this milestone reflects the company’s strong regulatory and quality systems under global standards and its ongoing commitment to addressing clinical needs for affordable biologic therapies. Henlius will continue to collaborate closely with Organon to advance the global availability of quality, affordable biologics for patients worldwide.”
BILDYOS is indicated for treatment of osteoporosis in postmenopausal women and in men at increased risk for fracture, treatment of bone loss associated with hormone ablation in men with prostate cancer at increased risk of fractures, and treatment of bone loss associated with long-term systemic glucocorticoid therapy in adult patients at increased risk of fracture. BILPREVDA is indicated for the prevention of skeletal related events in adults with advanced malignancies involving bone, and treatment of adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
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 each a biological medicine highly similar to another biological medicine already approved in the UK (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response).
In 2022, Henlius entered into a license and supply agreement with Organon, granting Organon the exclusive commercialization rights to several biosimilars, including BILDYOS and BILPREVDA. The agreement covers exclusive global commercialization rights except for China. 3
PROLIA and XGEVA are trademarks registered in the UK by Amgen, Inc.
【Reference】
1. PROLIA. Product Information. Amgen; 2025.
2. XGEVA. Product Information. Amgen; 2025.
3. Organon Enters into Global License Agreement to Commercialize Henlius’ Investigational Perjeta ®(Pertuzumab) and Prolia®/Xgeva ®(Denosumab) Biosimilar Candidates. Organon. June 13, 2022. Accessed September 15, 2025. https://www.organon.com/news/organon-enters-into-global-license-agreement-to-commercialize-henlius-investigational-perjeta-pertuzumab-and-prolia-xgeva-denosumab-biosimilar-candidates/