Last updated: February 22, 2026
What is NDC 55566-6500?
NDC 55566-6500 refers to Aflibercept (Eylea), a vascular endothelial growth factor (VEGF) inhibitor used primarily for the treatment of ocular diseases such as wet age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO).
Market Overview
| Feature |
Details |
| Indications |
Wet AMD, DME, RVO, myopic choroidal neovascularization (mCNV) |
| First FDA Approval |
November 2011 |
| Current Approved Brands |
Eylea (regulatory approved brand) |
| Manufacturer |
Regeneron Pharmaceuticals and Bayer, which co-markets Eylea |
| Competitive Landscape |
Bevacizumab (off-label), Ranibizumab, emerging biosimilars |
Market Size & Revenue
- The global retina drug market is projected to reach $10.5 billion by 2028.
- Eylea holds approximately 55% market share in this segment (as of 2023).
- U.S. sales of Eylea in 2022 totaled roughly $4.2 billion, representing stable growth from prior years.
Key Factors Impacting Market Size
- Growing prevalence: Ageing population increases AMD and DME cases.
- Off-label competition: Bevacizumab remains a cost-effective alternative, restricting Eylea's pricing power.
- New entrants: Biosimilars approved for related indications could pressure prices.
Pricing Overview
| Region |
Average Wholesale Price (AWP) per Dose |
Price Trends |
| U.S. |
~$2,100 |
Stable with slight increases annually |
| E.U. |
~$1,500 - $1,800 |
Slight discounts compared to U.S. |
| Canada |
~$2,200 |
Similar to U.S., with approval restrictions |
Price Components
- Per-dose cost: Based on a 0.3mL injection, typically administered every 4-8 weeks.
- Reimbursement: Varies by payer, with Medicare and private insurers leveraging negotiated rates.
- Manufacturing costs: Estimated to be 15-20% lower than retail prices due to economies of scale and biosimilar competition.
Pricing Trends & Projections (2023-2028)
| Year |
Projected Price per Dose |
Assumptions |
| 2023 |
$2,100 |
Stable, with no major patent expirations or biosimilar competition |
| 2024 |
$2,050 |
Slight downward pressure from biosimilar approvals in Europe |
| 2025 |
$2,000 |
Increase in biosimilar market share reducing prices |
| 2026 |
$1,850 |
Biosimilar penetration accelerates, especially in the U.S. |
| 2027 |
$1,700 |
Biosimilars capture 30-40% of the market, driving prices down |
| 2028 |
$1,650 |
Further biosimilar adoption, potential policy-driven price cuts |
Key Market Drivers for Price Changes
- Biosimilar development: Regulatory pathways in the U.S. (expected biosimilars by 2025) could reduce prices.
- Patent expirations: Major patents for Eylea have expired in the U.S. as of 2023, facilitating biosimilar entry.
- Healthcare policy: Increasing pressure for cost containment in the U.S. and Europe influences reimbursement rates.
Competitive Dynamics and Impact on Price
- Biosimilar competitors, such as Zirabev (biosimilar of Bevaziciumab), entered markets in 2021-2022, setting a precedent for Eylea biosimilar entry.
- Providers and payers are shifting toward more cost-effective off-label drugs, restraining Eylea’s pricing growth.
- Innovation in drug delivery, extended dosing intervals, and combination therapies could influence future pricing strategies.
Conclusion
NDC 55566-6500 (Eylea) has maintained high market share within retinal disease treatments thanks to proven efficacy and multiple approved indications. Despite stable revenues, the upcoming biosimilar landscape is expected to exert downward pressure on prices. Short-term stability is probable, with notable reductions projected from 2025 onward.
Key Takeaways
- Eylea remains a dominant retinal therapy, generating over $4 billion annually in U.S. sales.
- Price per dose has stabilized around $2,100, with moderate declines expected from biosimilar competition starting around 2025.
- The biosimilar entry will likely lead to a 20-25% reduction in average price per dose over the next three years.
- Patent expirations in 2023 facilitate biosimilar market entry, impacting future pricing strategies.
- Market growth is driven by demographic trends and increasing prevalence of retinal diseases.
FAQs
1. What factors could significantly alter the price projection for NDC 55566-6500?
Introduction of biosimilars in the U.S. or stricter reimbursement policies could accelerate price reductions or stabilize prices at lower levels.
2. How does biosimilar competition impact the market share of Eylea?
Biosimilars are expected to capture 30-40% of the market by 2026, reducing the market share and pricing power of Eylea.
3. Are there any regulatory hurdles that could delay biosimilar entry?
Yes. Regulatory approval depends on demonstrating biosimilarity and safety; delays could extend Eylea’s pricing stability.
4. What is the primary driver of Eylea’s revenue in the retinal treatment market?
The primary driver is its efficacy in treating multiple retinal diseases combined with its widespread use and reimbursement coverage.
5. How does the reimbursement landscape affect drug pricing?
Negotiated rates with payers and government programs influence the final price paid, affecting the overall revenue and pricing trajectory.
References
- EvaluatePharma. (2023). Global retinal drug market forecast.
- U.S. FDA. (2023). Approvals and patent statuses for Eylea and biosimilars.
- IQVIA. (2022). U.S. ophthalmic drug sales data.
- Biosimilars Council. (2022). Biosimilar market development updates.
- Centers for Medicare & Medicaid Services. (2022). Reimbursement policies for ophthalmic drugs.
