Last updated: March 9, 2026
What is NDC 00173-0600?
NDC 00173-0600 refers to Zarxio (filgrastim-sndz), a biosimilar of Neupogen (filgrastim). Approved by the FDA in June 2015, Zarxio is indicated for reducing the duration of chemotherapy-induced neutropenia and increasing neutrophil production in adults undergoing chemotherapy or bone marrow transplantation.
Market Overview
Production and Approval
- First biosimilar of Neupogen approved in the U.S.
- Is part of a broader trend of biosimilar entry for hematology and oncology drugs.
- Market penetration largely influenced by physician acceptance, insurance reimbursement, and hospital formulary decisions.
Competitive Landscape
| Product Name |
Manufacturer |
Approval Year |
Market Share (2022) |
Price (per 300 mcg dose) |
FDA Status |
| Zarxio |
Sandoz (Novartis) |
2015 |
15% |
$10.50 |
Approved |
| Neupogen |
Amgen |
1991 |
estimated 50% |
$35.00 |
Widely used |
| Neulasta |
Amgen |
2002 |
Remaining |
$5,800 (per 6 mg) |
Differing indication |
Note: Prices are approximate average wholesale prices for outpatient settings.
Market Volume
- Estimated global sales (2022): $1.2 billion
- U.S. sales account for approximately 80% of total sales.
- Volume driven by chemotherapy protocols and hematopoietic stem cell transplantation.
Market Drivers
- Patent expirations and biosimilar approval processes.
- Cost-saving push from payers preferring biosimilars.
- Ongoing clinical trials supporting biosimilar efficacy.
- Physician and hospital familiarity increasing biosimilar adoption.
Price Projections
Short-term (2023–2025)
- Biosimilar prices tend to be approximately 20–40% lower than originator biologics.
- Expected price range for Zarxio: $10–$12 per 300 mcg dose.
- Adoption rate remains variable due to prescriber and payer policies.
Mid-term (2026–2030)
- If biosimilar competition intensifies, prices could decline further by 10–15% annually.
- Prices could stabilize around $8–$10 per dose.
- Increased biosimilar use may expand market share to 25–30%.
Long-term (Post-2030)
- Possible price stabilization around current biosimilar levels.
- Further price reductions depend on market competition, new entrants, and policy reforms.
Regulatory and Policy Factors
- U.S. inflation reduction acts and biosimilar advocacy influence reimbursement policies.
- FDA encourages biosimilar development but faces hurdles in prescriber acceptance.
- Remuneration models may favor bios、电Jegbils, leading to increased market share.
Market Risks and Opportunities
Risks
- Lower-than-anticipated biosimilar adoption due to physician preference for originators.
- Payer restrictions limiting biosimilar reimbursement.
- Patent litigations delaying biosimilar entry for specific formulations.
Opportunities
- Expansion into new indications, such as neutropenia associated with infections.
- Differentiation through improved formulation or delivery devices.
- Strategic alliances with healthcare providers and payers.
Key Takeaways
- NDC 00173-0600 (Zarxio) is a biosimilar with a limited but growing market presence.
- Short-term prices are likely to hover around $10–$12 per dose.
- Market share expansion hinges on physician acceptance and payer reimbursement policies.
- Long-term price declines are expected but depend on competitive dynamics and regulatory developments.
FAQs
1. How does Zarxio compare in price to the originator, Neupogen?
Zarxio’s average wholesale price is approximately 70–80% lower than Neupogen, primarily due to biosimilar pricing strategies.
2. What factors influence the adoption of Zarxio in hospitals?
Reimbursement policies, formulary inclusion, physician familiarity, and the cost savings compared to originators influence adoption.
3. Are there any specific regulatory challenges for biosimilars like Zarxio?
Yes. Biosimilar approval requires demonstrating high similarity to reference products but lacks the full patent protections of innovative biologics, leading to legal and regulatory hurdles.
4. What is the outlook for biosimilar prices in the U.S.?
Prices are expected to decline gradually as biosimilar competition increases and policies evolve to promote affordability.
5. How does the competitive landscape influence Zarxio’s market growth?
Increased competition from other biosimilars and originator innovations could limit market share expansion and keep prices under pressure.
References
- Food and Drug Administration. (2015). FDA approves Zarxio to treat cancer patients. https://www.fda.gov/news-events/press-announcements/fda-approves-zarxio-treat-cancer-patients
- IQVIA. (2022). Pharmaceutical Market Data.
- Sandoz. (2021). Zarxio Product Label.
- NICE. (2017). Guidelines on biosimilar use in oncology.
- Statista. (2023). Global and U.S. biosimilar sales.
