By Fineline Cube 
Shandong Boan Biotechnology Co., Ltd. (HKG: 6955) announced that BA6101, its biosimilar version of Amgen’s Prolia (denosumab), received marketing approval from Bolivia’s AGEMED (Agencia Estatal de Medicamentos y Tecnologías en Salud). The 60mg injection for osteoporosis marks Boan’s first regulatory approval in South America and advances its global expansion strategy, with filings already under review in the UK and planned for Europe, the US, and Japan.
Regulatory Milestone
| Item | Detail |
|---|---|
| Product | BA6101 (denosumab biosimilar) |
| Company | Shandong Boan Biotechnology (6955.HK) |
| Approval | AGEMED (Bolivia) |
| Reference Drug | Prolia (Amgen originator) |
| Indication | Bone loss (osteoporosis) in at-risk patients |
| Dosage | 60mg injection |
| China Approval | December 2022 (marketed by BeiGene) |
| Global Strategy | UK under review; EU, US, Japan filings planned |
Market Opportunity
Denosumab Landscape:
- Global Sales: $4.5 billion (2025), with Prolia dominating the RANKL inhibitor market
- China Market: ¥3.2 billion (US$450 million) and growing at 12% CAGR
- Biosimilar Wave: 5‑6 denosumab biosimilars in global development; Boan is first Chinese company to secure ex‑China approval
Bolivia Opportunity:
- Addressable Patients: ~50,000 osteoporosis patients eligible for therapy
- Pricing: Projected $800‑1,200 annual cost (30% discount to originator)
- Peak Sales: $8‑12 million potential by 2028
Competitive Landscape
| Company | Product | Region | Stage | Differentiation |
|---|---|---|---|---|
| Amgen | Prolia (originator) | Global | Marketed | Brand leader |
| BeiGene | Prolia (China rights) | China | Marketed | Domestic distribution |
| Boan Bio | BA6101 | Bolivia | Approved | First Chinese biosimilar ex‑China |
| Sandoz | Denosumab biosimilar | EU | Under review | Established player |
| Samsung Bioepis | Denosumab biosimilar | US | Phase III | Late‑stage entrant |
Strategic Edge: Boan’s first‑mover advantage in Latin America and emerging markets creates proof‑of‑concept for global regulatory acceptance.
Global Expansion & Financial Impact
Filing Timeline:
- UK: Submission under review (MHRA); decision expected Q2 2026
- EU: Planned Q3 2026 filing via decentralized procedure
- US: 505(b)(2) pathway planned for 2027 (requires bridging studies)
- Japan: PMDA consultation initiated; filing targeted 2028
Manufacturing: Boan’s Yantai facility (capacity: 2 million units/year) is EU GMP‑certified, enabling global supply.
Peak Sales Potential:
- Ex‑China markets: $150‑200 million by 2030 (assuming 5% global biosimilar share)
- Total Portfolio Value: BA6101 could contribute ¥2 billion (US$280 million) to Boan’s revenue base
Forward‑Looking Statements
This brief contains forward‑looking statements regarding BA6101’s regulatory approvals, market penetration, and revenue forecasts. Actual results may differ materially due to competitive responses, pricing pressures, and regulatory review timelines.-Fineline Info & Tech