China-based Henlius Biotech has secured US regulatory approval for its denosumab biosimilars Bildyos (60mg/mL) and Bilprevda (120mg/1.7mL), covering all eight indications of Amgen and GSK's reference products Prolia and Xgeva for osteoporosis and bone metastasis complications. This marks China's first denosumab biosimilar approval overseas and Henlius' third US-approved product, following its 2022 USD 541 million licensing deal with Organon for ex-China commercialisation rights. The global denosumab market reached USD 7.46 billion in 2024.

Henlius demonstrated full development and manufacturing capabilities with 48,000-litre commercial capacity and 100% regulatory inspection pass rate. Marketing applications are underway in the European Union and Canada, with European Medicines Agency (EMA) approval anticipated following July 2025 positive opinion. The company's biosimilar success rate remains 100% across its portfolio, positioning it as a global leader in the sector through partnerships with Abbott, Sandoz and Dr. Reddy.

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