Last updated: February 15, 2026
Product Overview
NDC 00378-8760 corresponds to a monoclonal antibody (mAb) used for oncology, specifically a biosimilar version of Neulasta (pegfilgrastim). Neulasta is a long-acting granulocyte colony-stimulating factor (G-CSF) used to prevent neutropenia in chemotherapy patients.
Market Context
The global G-CSF market was valued at approximately USD 3.2 billion in 2022 and projected to grow at a CAGR of 8% through 2030, driven by increasing cancer treatment volumes and biosimilar entry [1].
Key Competitors
- Original brand: Amgen’s Neulasta
- Biosimilars: Multiple entrants including Mylan’s Fulphila, Sandoz’s Ziextenzo, and others.
- Market share distribution: Biosimilars accounted for roughly 35% of the G-CSF market in 2022, with continued growth expected.
Pricing Landscape
| Product |
Price per Dose (USD) |
Market Share (2022) |
Comments |
| Neulasta (brand) |
~$7,400 |
65% |
Premium pricing, high brand loyalty |
| Biosimilar A |
~$4,600 |
20% |
Discounted, competitive entry |
| Biosimilar B |
~$4,200 |
10% |
Lower-price competitor |
| Other biosimilars |
~$3,800 |
5% |
Pricing varies, limited market penetration |
Price reductions for biosimilars range from 30% to 50% below the brand price, driven by payer push for cost savings and patent expirations.
Pricing Assumption for NDC 00378-8760
Given its biosimilar status, initial launch price is expected at a 35-45% discount to Neulasta, falling within the mid-$4,000s per dose. Price decreases may occur in subsequent years as market penetration deepens, with discounts reaching up to 50% as competition intensifies.
Market Demand Projections
- In 2023, estimated annual sales volume: 400,000 doses globally.
- Growth driven by expanding indications and approval in emerging markets.
- Competitive pressure is likely to reduce average price per dose over the next 3-5 years.
Revenue Projections (2023-2027)
| Year |
Estimated Doses Sold |
Average Price per Dose (USD) |
Estimated Revenue (USD billions) |
| 2023 |
400,000 |
$4,500 |
1.8 |
| 2024 |
440,000 |
$4,200 |
1.85 |
| 2025 |
480,000 |
$4,000 |
1.92 |
| 2026 |
520,000 |
$3,850 |
2.00 |
| 2027 |
560,000 |
$3,700 |
2.07 |
Volume growth is moderate, driven by increased adoption and expansion into new markets; price declines occur due to intensified biosimilar competition.
Regulatory and Reimbursement Outlook
- European Medicines Agency (EMA) approved biosimilar pegfilgrastim in 2018.
- US FDA approval expected if not already obtained, with Medicare and private payers moving toward formulary inclusion based on cost-effectiveness.
- Payer negotiations may further constrain achievable pricing.
Key Market Risks
- Delays in regulatory approval can push launch dates.
- Patent litigations may Extend exclusivity periods.
- Healthcare policies favoring biosimilar substitution further pressures pricing.
Conclusion
NDC 00378-8760’s market hinges on biosimilar adoption rates, regional reimbursement policies, and competitive pricing strategies. Initial retail price estimates fall in the $4,200–$4,500 range per dose, trending downward over time due to market competition.
Key Takeaways
- Biosimilar pegfilgrastim face aggressive pricing pressures, with initial discounts of roughly 35-45% to Neulasta.
- Market share in oncology supportive care expands as biosimilar uptake accelerates.
- Revenue growth remains steady but decelerates as prices decrease in response to competition.
- Regulatory and reimbursement environments heavily influence pricing and sales volumes.
- Continued innovation and clinical data will determine long-term market positioning.
FAQs
-
When is NDC 00378-8760 expected to launch?
The launch depends on regulatory approvals, likely within 12 months if approvals are secured in key markets.
-
What factors influence biosimilar pricing?
Competition, payer negotiations, regulatory policies, and production costs.
-
How does the market penetration of biosimilars impact original biologics?
Biosimilars reduce market share and pressure pricing of the original biologics.
-
What regions are most lucrative for sales?
North America and Europe lead, followed by emerging markets in Asia-Pacific.
-
What are the main barriers to biosimilar adoption?
Physician and patient acceptance, reimbursement hurdles, and patent disputes.
Citations
[1] MarketsandMarkets, "G-CSF Market," 2022.
