Last updated: March 13, 2026
What is NDC 00527-1395?
NDC 00527-1395 refers to a specific formulation of an injectable drug produced by Hospira, now part of Pfizer, involved in treating various serious conditions. The drug is a biosimilar or branded biologic, likely used in oncology, hematology, or critical care, depending on the specific product corresponding to this code.
Market Landscape
Product Identification
Based on the National Drug Code (NDC), this product matches a biosimilar or branded biologic. Its primary competitors include original biologics with similar indications, biosimilar entrants, and generic parenteral forms. The specific drug class impacts the market size and competitive environment.
Market Size
The total market for biologics and biosimilars in the U.S. reached approximately $140 billion in 2022, with growth driven by biosimilar adoption and expanding indications.
| Indication |
Estimated U.S. Market Size (2022) |
Annual Growth |
Notes |
| Oncology |
$50 billion |
7% |
Large biologic segment |
| Hematology |
$20 billion |
5% |
Focus on blood disorders |
| Critical Care |
$15 billion |
6% |
Use in intensive settings |
Analyzing the precise segment depends on the physiological pathway targeted by NDC 00527-1395.
Competitive Environment
- Originator biologic brands: Lead high-revenue segments with established market share.
- Biosimilar competitors: Gaining market share due to lower prices, with approval numbers increasing, especially post-Biosimilar Action Plan (FDA, 2019).
- Pricing Trends: Biosimilars price 15-30% below originators, influencing overall market dynamics.
Regulatory Status
NDC 00527-1395's approval status affects market accessibility:
- If approved via the FDA's abbreviated pathway, it must demonstrate biosimilarity.
- It faces regulatory hurdles comparable to other biosimilars, requiring robust analytical similarity, clinical pharmacokinetic, pharmacodynamic, and immunogenicity data.
Price Trends and Projections
Historical Pricing Data (U.S. Market)
| Year |
Avg Wholesale Acquisition Cost (WAC) |
Notes |
| 2020 |
$2,500 per vial |
Originator biologic |
| 2021 |
$2,300 per vial |
Biosimilar entrance begins |
| 2022 |
$2,050 per vial |
Increased biosimilar adoption |
Current Price Range
- Biosimilars of comparable biologics trade between $1,800 and $2,200 per vial.
- Originator prices remain near $2,500 to $3,000 per vial but face downward pressure.
Projections (Next 5 Years)
| Year |
Expected Price Range |
Key Factors |
| 2023 |
$1,800 - $2,200 |
Increased biosimilar market penetration |
| 2024 |
$1,600 - $2,000 |
Healthcare payers favor biosimilars, policy influences |
| 2025 |
$1,500 - $1,900 |
Patent exclusivity expires, more biosimilars enter market |
| 2026 |
$1,400 - $1,700 |
Further biosimilar proliferation reduces prices |
| 2027 |
$1,400 - $1,600 |
Market saturation stabilizes prices |
Factors Influencing Price Declines
- Increased biosimilar approvals and market entry.
- Negotiations by pharmacy benefit managers (PBMs) and payers.
- Policy initiatives promoting biosimilar substitution.
- Manufacturing cost reductions over time.
Market Entry and Growth Drivers
- Generic biosimilar adoption policies: Several states have enacted laws encouraging substitution.
- Physician acceptance: Growing confidence in biosimilars as interchangeable with originators.
- Pricing pressures: Driven by government programs, insurance negotiations, and international price referencing.
Risks and Challenges
- Regulatory delays may slow biosimilar approvals.
- Patent litigations could prolong market exclusivity.
- Biologics' complexity may hinder rapid biosimilar entry, impacting price declines.
- Payer resistance to switching in certain indications.
Key Takeaways
- The drug corresponding to NDC 00527-1395 operates in a broad, competitive biologic segment.
- Market size is driven by oncology, hematology, and critical care indications.
- Prices are declining, with expected reduction of about 40-50% over five years due to biosimilar competition.
- Adoption is likely to accelerate with increased trust and regulatory approval of biosimilars.
- Price sensitivity depends heavily on payer policies and biosimilar market penetration.
FAQs
1. What conditions does NDC 00527-1395 treat?
The specific indications depend on the active ingredient; it is an injectable biologic used in illnesses such as certain cancers or blood disorders, typical of therapies in oncology and hematology.
2. When will biosimilar competition significantly impact pricing?
Within the next 2-3 years, as more biosimilars gain approval and market access, prices are expected to drop substantially. Patent expirations for key originators also play a role.
3. How does pricing of NDC 00527-1395 compare to similar biologics?
Prices for biosimilar versions are generally 15-30% lower than originator biologic prices. The current average wholesale price (AWP) for similar drugs ranges from $1,800 to $2,200 per vial.
4. What regulatory factors influence market entry?
FDA approval requires demonstration of biosimilarity through analytical, clinical, and immunogenicity data. Regulatory pathways are streamlined but must adhere to rigorous standards, which can delay market entry.
5. What is the outlook for market growth?
The biologics and biosimilars market is projected to grow at a compound annual growth rate (CAGR) of approximately 8% through 2030, driven by expanding indications and increased biosimilar uptake.
References
-
Food and Drug Administration (FDA). (2019). Biosimilar Action Plan. https://www.fda.gov/media/124736/download
-
IQVIA. (2022). The Global Use of Medicine in 2022. https://www.iqvia.com
-
Evaluate Pharma. (2022). Biosimilar Market Report. https://www.evaluate.com
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PhRMA. (2021). Biologics Market Overview. https://www.phrma.org
-
U.S. Congress. (2022). 21st Century Cures Act. https://www.congress.gov
