Last updated: February 24, 2026
What is NDC 70677-0163?
NDC 70677-0163 is the National Drug Code (NDC) number associated with Benralizumab (brand name: Fasenra). It is an injectable monoclonal antibody targeting IL-5 receptor alpha, approved by the FDA for severe eosinophilic asthma and related conditions.
Market Overview
Therapeutic Area: Severe Eosinophilic Asthma
- Market Size: Estimated at 150,000–200,000 US patients with severe eosinophilic asthma (IQVIA, 2022).
- Treatment Alternatives: Includes mepolizumab (Nucala), reslizumab (Cinqair), and dupilumab (Dupixent). These drugs collectively capture a significant share of the eosinophilic asthma market.
- Leading Competitors:
- Mepolizumab (Nucala): Approximate $4.4 billion global sales in 2022.
- Dupilumab (Dupixent): Over $8 billion in 2022.
- Pricing Context: Competitive with other monoclonal antibodies, with annual costs exceeding $30,000 per patient in the US.
Market Penetration to Date
- Uptake: Moderate initially, with increasing prescriptions driven by expanded indications (e.g., now approved for eosinophilic COPD).
- Prescribing Trends: Growing adoption in specialized asthma centers. The COVID-19 pandemic slowed initial uptake but recovery is underway as awareness increases.
Pricing Analysis
Current Price Benchmarks
| Drug |
Average Wholesale Price (AWP) per dose |
Cost per year (estimate) |
Indications |
| Benralizumab |
$5,300 per 30 mg injection |
~$31,800 (monthly dosing) |
Severe eosinophilic asthma |
| Mepolizumab |
~$4,000 per 100 mg injection |
~$48,000 annually |
Severe eosinophilic asthma |
| Reslizumab |
~$4,500 per 3 mg/kg infusion |
~$54,000 annually |
Severe eosinophilic asthma |
Note: All prices are approximate wholesale figures; patient net costs vary based on insurance and discounts.
Price Trends and Projections
- Historical Trends: Year-over-year price increases for monoclonal antibodies generally range 3-5%, driven by inflation, manufacturing costs, and value-based pricing strategies.
- Forecast (2023–2028):
- Incremental price increases of approximately 3% annually are expected.
- Potential for price stabilization or slight reductions due to biosimilar development or increased competition.
Market Entry & Competition Impact
- Biosimilars: No biosimilar for Benralizumab yet; regulatory pathways open, with some expected entrants by 2025.
- Impact on Price:
- Introduction of biosimilars typically reduces prices by 15-30% over 2-3 years.
- Payer negotiations and formulary positioning influence net prices, often pushing for discounts of up to 25%.
Revenue Projections
US Market
- 2022 Revenue: Estimated at $400 million.
- 2028 Forecast: With growth driven by increased adoption and expanded indications, revenue could reach approximately $900–$1 billion, assuming:
- Market share rises from 10% to 20% within the severe eosinophilic asthma segment.
- Average price per dose remains stable or sees slight inflation.
Global Market
- Global sales could reach $2–3 billion by 2028, assuming successful expansion into Europe, Asia, and emerging markets.
Strategic Considerations for Stakeholders
Key Takeaways
- NDC 70677-0163 (Benralizumab) is positioned in a competitive, high-growth monoclonal antibody market targeting severe eosinophilic asthma.
- US list prices hover around $5,300 per dose, with annual treatment costs exceeding $30,000.
- Price growth is expected to remain modest at around 3% annually but may decline under biosimilar competition.
- Market expansion into new indications and geographies supports revenue growth projections of 2x by 2028.
- Future pricing strategies will hinge on biosimilar developments, payer negotiations, and regulatory changes.
FAQs
Q1: What is the likely impact of biosimilar entry on Benralizumab pricing?
A1: Biosimilars could reduce prices by 15–30% within 2–3 years after approval, heightening competitive pressure.
Q2: How does the price of Benralizumab compare to other monoclonal antibodies in asthma?
A2: It is similar to mepolizumab, with average annual costs exceeding $30,000, and somewhat lower than reslizumab.
Q3: What are the main factors influencing Benralizumab’s market growth?
A3: Increasing prevalence of severe eosinophilic asthma, expanded indications, and physician familiarity.
Q4: How might regulatory or policy changes affect prices?
A4: Price regulation, value-based reimbursement policies, or increased use of biosimilars could exert downward pressure.
Q5: When are biosimilar competitors expected to enter the market?
A5: Regulatory approvals are anticipated around 2024–2025, with market entry shortly thereafter.
References
- IQVIA (2022). Therapeutic area analysis.
- FDA (2022). Biologics License Application approvals.
- Milliman (2022). Healthcare cost forecasts.
- Evaluate Pharma (2022). Market data and projections.
- IBM Watson (2022). Drug pricing analytics.
