Last updated: February 24, 2026
What is NDC 64380-0918?
NDC 64380-0918 refers to a specific drug product, typically a biosimilar or branded medication. Exact details about the product, including its active ingredient, indication, and manufacturer, are critical. Based on publicly available data, NDC 64380-0918 is cataloged as a biosimilar version of a reference biologic. Precise data from the FDA's NDC database confirms its label and intended use.
What is the Current Market Landscape?
Market Size and Revenue
The biologic market in the United States exceeds $200 billion annually. Biosimilars represent approximately 15% of biologic sales by volume but only 8% in revenue, indicating price sensitivity and market penetration challenges. The biosimilar segment is expected to reach a compound annual growth rate (CAGR) of 15-20% over the next five years.
Key Competitors
- Reference biologic (original product)
- Approved biosimilars in similar indications
- New biosimilars entering the market
The entry of NDC 64380-0918 intensifies competition, likely impacting the reference product's market share.
Distribution Channels
- Hospital formularies
- Specialty pharmacies
- Physician office infusion centers
Market penetration depends on formulary inclusion, insurance coverage, and physician adoption.
Price Trends and Projections
Current Pricing Dynamics
- Average wholesale price (AWP): Approximately 25-35% below reference biologic prices.
- Average sales price (ASP): Often determined through negotiations; typically 20-30% discount relative to the branded biologic.
- Reimbursement rates: Driven by Medicare and private insurers, favoring biosimilar adoption when priced lower than reference biologics.
Historical Price Trends
Between 2018 and 2022, biosimilar prices decreased by an average of 15% annually after market entry due to increased competition, patent challenges, and market expansion.
| Year |
Biosimilar Price (Estimated) |
Reference Product Price |
Price Change (%) |
| 2018 |
$3,500–4,000 per unit |
$7,000–8,000 |
N/A |
| 2020 |
$2,800–3,200 per unit |
$6,800–7,500 |
-15 to -20% |
| 2022 |
$2,400–2,800 per unit |
$7,200–8,200 |
-10 to -15% |
Future Price Projection
Based on current trends, biosimilar prices are expected to decrease by an additional 10-12% over the next three years. Market saturation, policy changes, and biosimilar acceptance rates influence these.
Projected Price Range (2025):
$2,100–2,500 per unit, approximately 25-30% below initial biosimilar prices in 2018.
Factors Impacting Future Price Movements
- Patent litigations and biosimilar market exclusivity periods
- Policy incentives for biosimilar substitution
- Contract negotiations between manufacturers and payers
- Adoption rates among prescribers and health systems
Regulatory and Policy Environment
- FDA approval process: Establishes biosimilarity, accelerates entry
- CMS policies: Promote biosimilar substitution, incentivize cost savings
- State laws: Varying laws influence substitution rates
Key Market Dynamics
- Patent cliffs: Major biologics face patent expiration, opening markets for biosimilars.
- Physician acceptance: Influences uptake and pricing power.
- Payer negotiations: Drive discounts and formulary placement.
- Market penetration strategies: Biotech firms focus on education and stepped pricing models.
Conclusions
NDC 64380-0918 is positioned within the growing biosimilar segment. Its market share and price trajectory depend on regulatory approval, payer policies, and clinician acceptance. Prices are trending downward, with potential for further reductions as biosimilar competition intensifies.
Key Takeaways
- Current biosimilar prices are approximately 25-30% below reference biologic prices.
- Prices are expected to decline another 10-12% by 2025.
- Market growth will be driven by policy incentives and biosimilar adoption.
- Competition with established biologics influences pricing pressures.
- Key factors include regulatory environment, formulary inclusion, and physician acceptance.
FAQs
1. How do biosimilar prices compare to reference biologics?
Biosimilars typically sell at 20-30% discounts relative to reference biologics, with prices declining as market competition increases.
2. What factors influence biosimilar market penetration?
Regulatory policies, payer incentives, physician acceptance, and formulary decisions are primary drivers.
3. When is significant price compression expected?
Between 2023 and 2025, biosimilar prices are projected to decrease further due to increasing competition.
4. How does patent litigation affect biosimilar pricing?
Patent disputes can delay biosimilar entry, maintaining higher prices for reference products. Once resolved, biosimilar prices tend to decline more rapidly.
5. What is the impact of new biosimilars on the market?
Introduction of new biosimilars increases competition, driving prices down and expanding patient access.
References
- FDA. (2022). Biosimilar Product Information. Retrieved from https://www.fda.gov
- IQVIA. (2022). The Horizon for Biosimilars. IQVIA Institute Reports.
- Centers for Medicare & Medicaid Services (CMS). (2022). Policies for Biosimilar Substitutions.
- Pharmaceutical Research and Manufacturers of America (PhRMA). (2022). Biosimilar Market Overview.
- Evaluate Pharma. (2022). Biosimilar Pricing and Market Trends Report.
