Shanghai Henlius Biotech, Inc. (HKG: 2696) and Organon (NYSE: OGN) announced that the European Commission (EC) has granted marketing authorization for two denosumab biosimilars: BILDYOS (60 mg/mL) and BILPREVDA (120 mg/1.7 mL). The approvals mirror the full range of indications held by Amgen’s originators, PROLIA and XGEVA, and follow their U.S. approval in August 2025.
Product Profile
| Biosimilar | Originator | Key Indications |
|---|---|---|
| BILDYOS | PROLIA | • Osteoporosis in post‑menopausal women and men at high fracture risk • Bone loss in men receiving hormone‑ablation therapy for prostate cancer • Bone loss in adults on long‑term systemic glucocorticoids |
| BILPREVDA | XGEVA | • Prevention of skeletal‑related events in adults with advanced bone‑involved malignancies • Treatment of giant‑cell tumor of bone in adults and skeletally mature adolescents when surgery is infeasible or would cause severe morbidity |
Strategic Context
- Global Supply Agreement – In 2022 Henlius and Organon entered a license and supply deal that grants Organon exclusive commercialization rights for BILDYOS and BILPREVDA outside China.
- Market Opportunity – The European denosumab market is projected to exceed €3 billion in 2026, driven by an aging population and rising prevalence of osteoporosis and bone‑metastatic cancers.
- Competitive Edge – These biosimilars offer comparable efficacy and safety to the originators while delivering a cost‑effective alternative for payers and clinicians.
Future Outlook
- Commercial Roll‑Out – Organon plans to launch BILDYOS and BILPREVDA across EU member states in Q4 2025, leveraging its established oncology and osteoporosis distribution networks.
- Pipeline Expansion – Henlius is advancing additional denosumab‑based biosimilars, including a low‑dose formulation for pediatric osteoporosis, slated for EU submission in 2026.
- Regulatory Momentum – The dual EC approvals reinforce Henlius’s reputation as a leading biosimilar developer and could position the company for further collaborations with global biopharma partners.-Fineline Info & Tech
