By Fineline Cube 
Shanghai Henlius Biotech, Inc. (HKG: 2696) announced that the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has granted marketing authorisation for its two denosumab biosimilars, BILDYOS and BILPREVDA. The authorisation covers all approved indications of the reference products (Amgen’s Prolia® and Xgeva®).
Product Portfolio
| Biosimilar | Reference Product | Indication Highlights |
|---|---|---|
| BILDYOS | Prolia (denosumab 60 mg) | • Osteoporosis in post‑menopausal women & men at high fracture risk • Bone loss from hormone ablation in prostate‑cancer patients • Glucocorticoid‑induced bone loss in adults |
| BILPREVDA | Xgeva (denosumab 120 mg) | • Prevention of skeletal‑related events in adults with advanced bone‑involved malignancies • Treatment of unresectable giant‑cell tumour of bone (adults & skeletally mature adolescents) |
Regulatory Rationale
- Data Package: Comprehensive analytical, functional, PK, and comparative clinical data demonstrated high similarity to the reference biologics in structure, biological activity, efficacy, safety, and immunogenicity.
- Clinical Confirmation: A head‑to‑head comparative trial met the MHRA’s biosimilarity criteria, confirming no clinically meaningful differences.
Commercial Landscape
- 2022 Organon License: Henlius signed a license and supply agreement with Organon granting the latter exclusive global commercialisation rights for BILDYOS and BILPREVDA outside of China.
- Market Opportunity: The UK osteoporosis market is valued at ≈ £2.3 bn, while the bone‑metastasis segment exceeds £1.5 bn. Entry of cost‑competitive biosimilars is expected to intensify price pressure and expand patient access.
- Revenue Outlook: Henlius projects £45–£60 m in 2026 UK sales from the two biosimilars, with upside potential from future European submissions.
Strategic Implications
- Portfolio Diversification: Adds two high‑value biologics to Henlius’s growing biosimilar pipeline, reinforcing its position as a leading Chinese biosimilar exporter.
- Geographic Reach: The MHRA approval serves as a regulatory “gateway” for further EU and Commonwealth market submissions.
- Partnership Leverage: Organon’s commercial expertise accelerates market penetration while Henlius retains full rights in its domestic market, preserving a strong revenue stream at home.
Forward‑Looking Statements
This brief contains forward‑looking statements regarding regulatory timelines, commercial performance, and strategic benefits of the MHRA approvals. Actual results may differ due to risks including regulatory changes, competitive dynamics, pricing pressures, and execution of partnership agreements.-Fineline Info & Tech