Last updated: February 24, 2026
What is NDC 51079-0917?
NDC 51079-0917 is a biosimilar drug, specifically a biosimilar version of a reference biologic therapy. It is marketed under the brand name Zarxio (filgrastim-sndz) by Sandoz, a Novartis division. Zarxio is used to stimulate the production of white blood cells, primarily in patients undergoing chemotherapy or stem cell transplantation.
Market Overview
Market Size and Growth Trends
The global growth of biosimilars is driven by patent expirations of innovative biologics, regulatory pathways facilitating biosimilar approvals, and healthcare cost containment efforts. In 2022, biosimilar sales surpassed $35 billion globally, increasing at a compound annual growth rate (CAGR) of approximately 20-25% since 2018.
Competition Landscape
Key competitors to Zarxio include:
Regulatory Status
Zarxio received FDA approval in 2015 as the first biosimilar for filgrastim. It is approved for the same indications as the reference product Neupogen, including neutropenia associated with chemotherapy and stem cell transplantation.
Pricing Landscape
Current Pricing
Retail list prices for biosimilars like Zarxio vary by region:
| Region |
Approximate Price per 300 mcg/0.5 mL Dose |
Notes |
| U.S. |
~$250 |
Lower than Neupogen's original price (~$700), but significantly higher than generics for small molecules. |
| Europe |
€120-150 |
Prices are negotiated under national health systems. |
| Canada |
CAD 300-350 |
Negotiated prices often lower than initial list prices. |
Price Trends
From 2018 to 2022, biosimilar prices decreased by 30-50% in competitive markets, driven by increased market penetration and payer negotiations. Price erosion stabilizes around 25-30% below reference biologic prices.
Market Share & Penetration
Current Market Share (2023)
Zarxio holds approximately 40-50% of the biosimilar filgrastim market in the U.S., competing mainly with Neupogen and other biosimilars like Grastofil. The remaining share is split among brand and biosimilar products.
Adoption Factors
- Physician familiarity with biosimilars.
- Payer policies favoring biosimilar use.
- Cost savings for healthcare providers.
Price Projections
Short-term (2023-2025)
- Price stabilization occurs as biosimilars reach maximum market penetration in mature markets.
- List prices for Zarxio are projected to decrease by an additional 10-15%, reaching approximately $200-225 per dose by 2025.
- Negotiated prices in public and private payers will likely be 20% lower than list prices.
Mid-term (2026-2030)
- Increased competition from subsequent biosimilars may lead to further price erosion of 20-25% relative to 2025 levels.
- Expected to reach $150-$170 per dose in the United States.
- Europe and other regions may see similar trends but at different levels due to pricing policies.
Key Influences
- The entrance of new biosimilars.
- Policy shifts favoring biosimilar substitution.
- Changes in healthcare reimbursement structures.
Strategic Implications
- Market growth depends on biosimilar acceptance, physician prescribing behaviors, and payer negotiating power.
- Pricing strategies should anticipate continuous price decreases but could offset this with volume growth.
- Regional variations require tailored market approaches, especially in Europe, where price controls are more stringent.
Key Takeaways
- NDC 51079-0917 corresponds to Zarxio, a biosimilar of Neupogen, with a significant market share in the biosimilar filgrastim sector.
- Global biosimilar sales are growing at a CAGR of 20-25%, with prices decreasing by approximately 30-50% since 2018.
- List prices currently hover around $250 per dose in the U.S., with future reductions expected to 2025, reaching around $200-$225.
- Market penetration and payer policies will influence future price erosion.
- Competition from new biosimilars and regional policy differences will shape the landscape through 2030.
FAQs
1. What factors influence biosimilar pricing compared to reference biologics?
Payer negotiations, market competition, manufacturing costs, and regulatory policies heavily influence biosimilar pricing, often resulting in lower prices due to increased competition.
2. How does biosimilar acceptance impact market share?
Higher acceptance by physicians and payers increases biosimilar market share, which in turn pressures prices downward and encourages further adoption.
3. What is the typical price difference between biosimilars and originator biologics?
Biosimilars generally cost 15-30% less than originator products; in some markets, discounts range up to 50% or more.
4. How do regional policies affect biosimilar pricing and adoption?
Countries with strict price regulation and policies favoring biosimilar uptake see faster adoption and lower prices compared to markets with less regulation.
5. When is the expected expiration of patents affecting Zarxio's market?
The original patent for Neupogen expired in 2015 in the U.S., enabling biosimilar entry; Zarxio's exclusivity period typically extends a few years after approval, with generic biosimilar competition increasing thereafter.
References
[1] IMS Health. (2022). Global Biosimilar Market Report.
[2] U.S. Food and Drug Administration. (2015). Approval letter for Zarxio.
[3] IQVIA. (2022). Biosimilar Market Insights.
[4] European Medicines Agency. (2021). Biosimilar Guidance.
[5] Centers for Medicare & Medicaid Services. (2022). Biosimilar Reimbursement Policies.
