Last updated: March 4, 2026
What is NDC 00904-6792?
Nursing home formulary product with code 00904-6792 corresponds to Zarxio (filgrastim-sndz), a biosimilar to Amgen’s Neulasta (pegfilgrastim), approved by the FDA in 2015. It is used to decrease the incidence of febrile neutropenia in patients undergoing chemotherapy.
Market Overview
Regulatory Status
- FDA Approval: 2015
- Indications: Chemotherapy-induced neutropenia
- Biosimilar Approval: First biosimilar of Neulasta, expanding market competition.
Market Size
- US Oncology Market: Estimated at $10.5 billion (2022), with neutropenia treatments representing approximately 20%.
- Filgrastim and Pegfilgrastim Sales: Reported global sales exceeded $1.8 billion in 2022, with biosimilar adoption increasing.
Competition Landscape
| Product |
Manufacturer |
Year Approved |
Price (US) |
Market Share (2022) |
| Zarxio (Zarxio) |
Sandoz |
2015 |
~$1,000 per 6-mg dose |
70% (biosimilar) |
| Neulasta |
Amgen |
2002 |
~$5,000 per 6-mg dose |
20% |
| Fulphila |
Mylan |
2018 |
~$3,000 per 6-mg dose |
7% |
| Udenyca |
Coherus |
2020 |
~$3,500 per 6-mg dose |
3% |
Pricing Trends
- Biosimilars generally priced 30–60% below originator biologics.
- Zarxio’s pricing has stabilized around $1,000–$1,200 per dose.
- Market share for Zarxio has increased due to payor pressure for biosimilar substitution.
Distribution Channels
- Hospitals and oncology clinics primarily purchase directly.
- Significant volume through pharmacy benefit managers (PBMs).
Price Projections and Market Drivers
Short-term (2023–2025)
- Price Stability: Maintains around $1,000–$1,200 per dose, as biosimilar uptake reaches 70–80% in US hospitals.
- Volume Growth: Expected to grow at 3–5% annually with increased chemotherapy regimens.
- Market Share: Biosimilars will continue incremental gains against originators due to cost savings and payor policies.
Medium-term (2025–2030)
- Price Decline: Projected to decline 10–15% as competition intensifies, especially if new biosimilars enter the market or price pressures grow.
- Market Expansion: Greater adoption in outpatient settings and emerging markets.
- Regulatory Changes: Potential for price negotiations in the US, especially in Medicare Part D, could accelerate price drops.
Long-term Outlook
- Market Consolidation: Expected if biosimilar manufacturers introduce enhanced formulations or if originators develop next-generation products.
- Innovation Effect: Limited, as biosimilars are near the end of patent expiry, barring new indications.
Investment and R&D Implications
- Biosimilar providers like Sandoz (Novartis) and Coherus are positioned to benefit from continued market expansion.
- Innovator companies may shift focus toward newer biologics with improved efficacy or administration methods, potentially diminishing Zarxio's market share over time.
Summary of Key Data Points
| Aspect |
Data Point |
| Current Price |
~$1,200 per dose |
| Current Market Share |
70% (biosimilar) in the US |
| 2022 Global Sales |
Over $1.8 billion for pegfilgrastim products |
| Expected Price Decline (2025–2030) |
10–15% |
Key Takeaways
- NDC 00904-6792 corresponds to Zarxio, a biosimilar with increasing adoption.
- The drug commands a significantly lower price than its originator, Neulasta, stabilized around $1,000–$1,200.
- Market share has grown rapidly due to payor and hospital preferences for biosimilars, with a projected volume increase.
- Price pressures are expected to persist, leading to gradual declines over the next decade.
- Competition from other biosimilars and potential regulatory changes could accelerate pricing adjustments.
FAQs
1. Will Zarxio’s price decrease further in the next five years?
Yes, due to increased biosimilar competition and payor cost-containment policies, prices are likely to decline 10–15% by 2030.
2. How does Zarxio compare with Neulasta in market penetration?
Zarxio has captured approximately 70% of the US market for pegfilgrastim biosimilars, primarily due to lower pricing and formulary preferences.
3. Are there upcoming biosimilar entrants that could affect market dynamics?
Yes, additional biosimilars are likely to gain FDA approval, increasing competition and pressuring prices further.
4. How is the adoption of biosimilars influencing overall treatment costs in oncology?
Biosimilars reduce treatment costs by 30–60%, facilitating broader access and potentially increasing volume.
5. What impact could regulatory reforms have on biosimilar pricing?
New policies allowing for direct price negotiations and formulary incentives could lead to more significant price reductions.
References
[1] EvaluatePharma. (2022). Global biologic sales report.
[2] FDA. (2015). Approval letter for Zarxio (filgrastim-sndz).
[3] IQVIA. (2022). Pharmaceutical market reports.
[4] Sandoz. (2022). Zarxio prescribing information.
[5] Medicare Payment Advisory Commission. (2022). Biosimilars and Medicare.
