Henlius Biotech gets EU nod for denosumab biosimilars BILDYOS, BILPREVDA

Shanghai Henlius Biotech, Inc. announced the European Commission (EC) has approved marketing authorization applications for BILDYOS® and BILPREVDA®, two products of HLX14 (denosumab). These approvals cover all EU Member States, as well as Iceland, Liechtenstein, and Norway, for indications including osteoporosis and skeletal-related events in advanced malignancies.

The EC's decision follows a comprehensive review of comparative study data between HLX14 and the reference product, Prolia®, demonstrating analytical similarity and comparable clinical efficacy and safety. The company received two GMP certificates in June 2025 from Belgium's Federal Agency for Medicines and Health Products, confirming EU GMP standards for HLX14 production lines.

This European approval follows earlier approvals for BILDYOS® and BILPREVDA® in the United States in August 2025 for eight indications. Henlius has a licensing agreement with Organon LLC for global commercialization of HLX14, excluding mainland China, Hong Kong, Macau, and Taiwan. Global sales of denosumab in 2024 were approximately $7.463 bn.