Fosun Pharma's HLX14 biosimilar wins EU approval for multiple indications

Shanghai Fosun Pharmaceutical Group announced that its controlled subsidiary, Shanghai Henlius Biotech, has received European Commission approval for its two denosumab injection products, BILDYOS® (60 mg/mL) and BILPREVDA® (120 mg/1.7mL), with the project code HLX14. These products are approved for all indications for which the reference products, Prolia® and XGEVA®, are approved in the EU, including osteoporosis and prevention of skeletal-related events in cancer patients. This approval extends to all EU member states, as well as Iceland, Liechtenstein, and Norway.

The EU approval follows previous regulatory milestones, including US approval in August 2025 for eight indications and a New Drug Submission in Canada in September 2024. As of July 2025, the total R&D investment for HLX14 by the group is approximately RMB 323m. According to IQVIA MIDAS™ data, denosumab injection products generated approximately $7.463bn in global sales in 2024.

The commercialization rights for HLX14 outside of China (including Hong Kong, Macao, and Taiwan) were granted to Organon LLC in June 2022. Henlius will receive sales milestones and royalties under this license agreement. However, the company cautioned investors that actual sales performance post-launch is subject to market demand, competition, and distribution channels, introducing a degree of uncertainty.