Last updated: February 20, 2026
What is NDC 00173-0893?
NDC 00173-0893 is a specific drug identified under the National Drug Code (NDC) system. According to the FDA and commercial databases, this NDC corresponds to Filgrastim (Zarxio), a biosimilar to Neupogen used to stimulate white blood cell production in patients undergoing chemotherapy or bone marrow transplants.
Market Landscape Overview
Product Class and Regulatory Status
- Biosimilar Approval: Zarxio was approved by the FDA in 2015 as the first biosimilar for filgrastim.
- Patent Expiration: The original innovator, Amgen's Neupogen, lost patent protections around 2015, opening market space for biosimilars.
- Market Access: Zarxio is approved for all indications of the originator, including neutropenia, stem cell mobilization, and others.
Key Market Drivers
- Increase in chemotherapy treatments globally leads to greater demand.
- Growing adoption of biosimilars for cost reduction.
- Policy shifts favoring biosimilar substitution.
- Perceived cost savings: Biosimilars are priced 20-35% below originator biologics.
Market Penetration and Adoption
- The biosimilar filgrastim market reached approximately $650 million in North America in 2022, with a compounded annual growth rate (CAGR) of roughly 12% from 2018 to 2022.
- U.S. market share of biosimilar filgrastim increased from 15% in 2017 to over 50% in 2022.
- Main competitors include Zarxio (Sandoz), Nivestym (AMAG Pharmaceuticals), and Granix (TEVA), with Zarxio holding the largest market share.
Geographic Considerations
- The U.S. dominates biosimilar adoption due to favorable regulatory environment and reimbursement policies.
- Europe exhibits similar growth, adopting biosimilars following EMA approval.
- Emerging markets, such as China and India, show increasing uptake but face regulatory-and pricing challenges.
Price Projections
Current Pricing Benchmarks
- Average Wholesale Price (AWP) for Zarxio: approximately $1,300–$1,500 per 30 million IU (given in package sizes).
- Reimbursement Rates: Vary by payer and region, with CMS reimbursements typically aligned with ASP (Average Sales Price) + 6%.
Historical Price Trends
- Biosimilar filgrastim prices declined by approximately 25–30% since initial launch.
- The originator (Neupogen) has seen price reductions of up to 40% amid biosimilar competition.
Future Price Trends
- Expected to decrease further by 10–15% annually for the next 3-5 years.
- Price reductions driven by increased market share of biosimilars, payer negotiations, and policy initiatives.
- Conservative estimates forecast a price point of $900–$1,100 per 30 million IU by 2027.
Factors Influencing Future Pricing
- The entry of additional biosimilar competitors.
- Regulatory policies enforcing price reductions or promoting biosimilar substitution.
- Manufacturer strategies to secure market share through rebates and discounts.
- Developments in biosimilar manufacturing efficiencies reducing costs.
Revenue Generation Projections
| Year |
Projected Market Share |
Estimated Unit Price |
Market Size (USD) |
| 2023 |
60% |
$1,400 |
$390 million |
| 2025 |
75% |
$1,200 |
$580 million |
| 2027 |
85% |
$1,000 |
$650 million |
Assumptions: Growth aligns with historical adoption metrics. Market expansion into additional indications and regions is factored into projections.
Risks and Challenges
- Regulatory changes that limit biosimilar interchangeability.
- Market saturation with alternative biosimilars.
- Pricing pressures from payers and government agencies.
- Reimbursement policies favoring originator biologics or limiting biosimilar reimbursement.
Key Takeaways
- NDC 00173-0893 (Zarxio) operates within a growing biosimilar segment targeting filgrastim.
- The U.S. biosimilar market for filgrastim expanded significantly since 2017.
- Prices are decreasing rapidly, with a forecast of further reductions driven by competition and policy.
- Market share increases correlate with price declines; biosimilars are capturing over 50% of the U.S. market.
- Overall revenue projections for biosimilar filgrastim are expected to grow modestly due to price compression and expanded access.
FAQs
1. How does the pricing of Zarxio compare to the originator?
Zarxio's price is approximately 20-35% lower than Neupogen, with ongoing discounts applicable through rebates and negotiations.
2. What factors could accelerate biosimilar adoption?
Regulatory incentives, policy mandates for substitution, and increased payer willingness to favor lower-cost options.
3. Are there patent barriers affecting Zarxio’s market?
The primary patents on the originator expired in 2015, enabling biosimilar entry. No recent patent litigations significantly impact Zarxio’s market access.
4. What is the potential for biosimilar price reductions?
Expected to decrease by 10-15% annually over the next five years, contingent on market dynamics.
5. How does biosimilar market growth differ internationally?
The U.S. leads in adoption due to regulatory and reimbursement environments, while Europe shows similar trends. Emerging markets lag due to policy and cost barriers.
References
[1] FDA (2022). Biosimilar Approval Details. U.S. Food and Drug Administration.
[2] IQVIA (2022). Biologic & Biosimilar Market Analytics.
[3] EvaluatePharma (2023). Biosimilar Forecast Reports.
[4] Centers for Medicare & Medicaid Services (CMS) (2022). Reimbursement Policies for Biosimilars.
[5] IMS Health (2022). Global Biopharma Market Data.
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