By Fineline Cube 
Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (HKG: 2196, SHA: 600196) announced that the Biologics License Applications (BLAs) for its subsidiary Henlius’ self‑developed denosumab injection (project code: HLX14) have been cleared by the U.S. Food and Drug Administration (FDA).
Dual‑Dose Biosimilar Portfolio
Henlius has brought to market two formulations that mirror Amgen’s flagship denosumab products:
| Formulation | Trade Name | Volume | Dose | Indication | FDA Status |
|---|---|---|---|---|---|
| 60 mg/mL | BILDYOS | 1 mL | 60 mg | Osteoporosis in post‑menopausal women at high risk for fractures | Approved |
| 120 mg/1.7 mL | BILPREVDA | 1.7 mL | 120 mg | Osteoporosis in post‑menopausal women at high risk for fractures | Approved |
Both biosimilars are fully human monoclonal antibodies that competitively inhibit RANKL, the same mechanism of action as the originator denosumab (Prolia and XGEVA).
Regulatory Milestone
- FDA BLA Approval – The FDA granted full approval for both BILDYOS and BILPREVDA on 12 March 2025, marking the first time a Chinese‑based biosimilar has received clearance for both dose strengths in the U.S. market.
- Label Consistency – The approved indications match those of the originator, covering osteoporosis in post‑menopausal women at high risk for fractures.
- Quality Assurance – Henlius’ analytical, pre‑clinical, and clinical data demonstrated bioequivalence to the reference product, meeting the stringent FDA biosimilar guidelines.
Market Implications
- Competitive Pricing – With a proven biosimilar supply chain, Fosun can offer cost‑effective alternatives to Prolia and XGEVA, potentially capturing a significant share of the U.S. osteoporosis market projected to exceed $6 billion by 2030.
- Strategic Expansion – The FDA approval unlocks additional opportunities for Henlius to pursue biosimilar indications beyond osteoporosis, including bone metastases and rheumatoid arthritis.
- Global Reach – Fosun plans to leverage its international distribution network to introduce BILDYOS and BILPREVDA in major markets such as Europe, Canada, and Japan, where biosimilar uptake is accelerating.
Next Steps
- Commercial Launch – Henlius is preparing to roll out the products through its U.S. sales force and specialty pharmacy partners, with initial launch scheduled for Q4 2025.
- Payer Engagement – The company will engage with Medicare, Medicaid, and commercial insurers to secure favorable formulary placement and reimbursement rates.
- Post‑Marketing Surveillance – Robust pharmacovigilance plans will be implemented to monitor long‑term safety and efficacy, ensuring continued confidence among prescribers and patients.-Fineline Info & Tech