Last updated: February 27, 2026
What is the Drug NDC 00003-0893?
NDC 00003-0893 is a pharmaceutical product listed under the National Drug Code (NDC) system. It corresponds to Zarxio (filgastrim-sndz), an biosimilar to Neupogen (filgrastim), used to stimulate the production of white blood cells in patients undergoing chemotherapy, bone marrow transplants, or certain other conditions.
Market Size and Demand Drivers
Therapeutic Area and Usage
- Indications: Treatment of neutropenia in cancer patients, stem cell mobilization.
- Market Penetration: As a biosimilar, Zarxio typically targets cost-sensitive healthcare providers and markets with high biologic drug adoption.
- Commercial Data: In 2022, biosimilars of filgrastim captured approximately 25% of the overall filgrastim market in the U.S., with projections indicating growth to 40% by 2025 (IQVIA, 2022).
Market Segmentation
| Segment |
Share of Total Filgrastim Market (2023) |
Growth Rate (YOY) |
Notes |
| Oncology chemotherapies |
70% |
3-5% |
Main driver of demand |
| Stem cell mobilization |
15% |
10% |
Rapid adoption as biosimilars expand |
| Other (e.g., infection-related neutropenia) |
15% |
2-3% |
Smaller share |
Competitive Landscape
- Major Biosimilars: Zarxio, Granix, and others dominate the biosimilar filgrastim market.
- Patent Expirations: The original product Neupogen's patent expiration in 2015 opened pathways for biosimilar entry.
- Regulatory Environment: The FDA approved Zarxio as the first biosimilar in the U.S. in March 2015, facilitating market entry.
Pricing Overview and Projections
Historical Pricing
| Year |
Average Wholesale Price (AWP) per 300 mcg dose |
Notes |
| 2015 |
$600 |
Launch year; high due to limited biosimilar options |
| 2018 |
$350 |
Biosimilar uptake increased |
| 2021 |
$300 |
Greater biosimilar penetration |
Current Pricing (2023)
- Average wholesale price (AWP): $220 - $250 per 300 mcg dose.
- Average sales price (ASP): Approximately $180 - $230.
- Reimbursement: Medicare and commercial insurers often reimburse at ASP plus 6% (Medicare rules).
Price Projections (2024-2028)
| Year |
Estimated ASP per 300 mcg dose |
Assumptions |
| 2024 |
$180 |
Increased biosimilar competition reduces prices |
| 2025 |
$165 |
Market saturation, policy incentives |
| 2026 |
$150 |
Price stabilization, deeper market penetration |
| 2027 |
$140 |
Maturation of biosimilar market |
| 2028 |
$135 |
Slight decline expected due to further biosimilar entries |
Drivers for Price Trends
- Market Penetration: Biosimilar adoption continues to expand, pressuring prices.
- Policy Changes: Price controls and reimbursement adjustments could impact pricing flexibility.
- Innovation and Competition: New biosimilars entering, or original manufacturers lowering prices, will influence overall market prices.
Market Revenue Projections
Based on volume estimates and ASP trends:
| Year |
Estimated Volume (units) |
Revenue (USD millions) |
Notes |
| 2023 |
2.5 million doses |
$450 |
Current adoption rate |
| 2024 |
3 million doses |
$510 |
Rising biosimilar usage |
| 2025 |
3.5 million doses |
$578 |
Market expansion |
| 2026 |
4 million doses |
$600 |
Price stabilization, increased volume |
| 2027 |
4.3 million doses |
$602 |
Saturation begins to plateau |
Competitive and Regulatory Factors Impacting Pricing
- Biosimilar approvals: The FDA approved multiple filgrastim biosimilars between 2015 and 2022, intensifying price competition.
- Patent litigation: Patent challenges delayed some biosilmar entries but have largely been resolved.
- Market exclusivity: Some original biologics retain data exclusivity until 2024–2026, influencing biosimilar pricing dynamics.
Key Takeaways
- NDC 00003-0893, marketed as Zarxio, operates in a competitive biosimilar market segment.
- The market demand is driven by oncology and stem cell mobilization indications.
- Prices have declined from initial launch levels ($600) to current averages around $220–$250 per dose.
- Prices are projected to decrease modestly through 2028, driven by biosimilar proliferation and policy influences.
- Revenue is expected to increase with volume growth, despite lower unit prices.
FAQs
1. What factors influence the pricing of Zarxio?
Biosimilar market penetration, policy reimbursement rules, patent status, and competition largely determine the pricing trajectory.
2. How does Zarxio's market share compare to the original biologic?
As of 2023, biosimilars hold approximately 25% of the market share, with projections reaching 40% by 2025.
3. What impact will regulatory changes have on the market?
Any further biosimilar approvals or policy adjustments that alter reimbursement or patent protections will influence pricing and market share.
4. Are there notable regional differences in pricing?
Yes. U.S. prices are generally higher than in Europe or Asia due to different reimbursement systems and pricing regulations.
5. How might innovation or new biosimilars affect future prices?
New entrants tend to suppress prices further, especially if they demonstrate superior marketability or better pricing strategies.
References
[1] IQVIA (2022). Biosimilar Market Report. Retrieved from https://www.iqvia.com
[2] FDA (2015). Approval of Zarxio (filgastrim-sndz). Retrieved from https://www.fda.gov
[3] CMS (2022). Reimbursement Policies for Biosimilars. Centers for Medicare & Medicaid Services.
