Last updated: February 26, 2026
What is NDC 31722-0774?
NDC 31722-0774 identifies Udenyca (pegfilgrastim-jmdb), a biosimilar to Neulasta (pegfilgrastim), approved by the FDA in 2019. It is used to reduce the incidence of febrile neutropenia in patients undergoing chemotherapy.
Market Landscape
Product Profile
- Therapeutic Class: Hematopoietic agents; growth factors
- Indications: Prevention of neutropenia in adult cancer patients receiving myelosuppressive chemotherapy
- Manufacturer: Coherus Biosciences
- Approval Date: December 19, 2019
Market Size and Growth
- The global pegfilgrastim market was valued at approximately $2.8 billion in 2022.
- Expected to grow at a compound annual growth rate (CAGR) of around 8% through 2027, driven by increasing cancer prevalence and adoption of biosimilars.
Competitive Landscape
| Product Name |
Manufacturer |
Approval Year |
Market Share (2022) |
Price per Dose (Approx.) |
| Neulasta (reference) |
Amgen |
2002 |
65% |
$8,500–$9,400 |
| Udenyca |
Coherus Biosciences |
2019 |
10% (estimated) |
$3,500–$4,200 |
| Fulphila |
Mylan/Biocon |
2018 |
12% |
$3,600–$4,200 |
| Neulasta OnPro |
Amgen |
2015 |
10% |
$9,500 |
Key Market Dynamics
- Patent expirations and biosimilar approvals have increased competition.
- Payers favor biosimilars due to lower costs.
- Prescribing habits are shifting towards biosimilars, especially in markets with strong payor incentives.
Price Projections
Current Average Price
- Dose price of Udenyca averages $3,500–$4,200, significantly under the reference biologic.
Short-term Outlook (Next 1-2 Years)
- Price stabilization: Biosimilar prices are expected to stay within current ranges.
- Market share expansion: Increased physician acceptance and payer coverage could elevate Udenyca's market share to 15-20%.
- Pricing pressure: Entry of additional biosimilars may push prices downward by 10-15%.
Medium-term Outlook (3-5 Years)
- Price decline: Continued genericization and biosimilar competition could reduce prices by 20-25%.
- Value-based pricing models may influence net prices, potentially creating discounts tied to real-world outcomes.
Long-term Projections (5+ Years)
- Prices could stabilize at $2,500–$3,000 per dose, assuming multiple biosimilars compete in the market.
- Market penetration depends on regulatory, clinical, and payer acceptance.
Revenue Implications
| Estimate based on prescriber adoption: |
Assumption |
2022 |
2025 (Projection) |
2027 (Projection) |
| Units sold annually |
200,000 |
330,000 |
500,000 |
| Average price per dose |
$3,700 |
$3,200 |
$2,800 |
| Annual revenue |
$740 million |
$1.056 billion |
$1.4 billion |
Strategic Considerations
- Companies should monitor biosimilar pipeline developments.
- Payer policies may accelerate switching to biosimilars.
- Price discounts from contract negotiations can influence net revenues.
Key Takeaways
- Udenyca holds about 10% of the pegfilgrastim market, with potential to grow.
- Prices are currently 40-60% lower than Neulasta.
- Market expansion hinges on acceptance, payer coverage, and regulatory policies.
- Long-term price declines are likely, with stabilization possible in 5–7 years.
- Revenue depends on units sold, market penetration, and pricing strategies amid competitive pressures.
FAQs
1. How does Udenyca's pricing compare to Neulasta?
Udenyca's dose costs approximately $3,500–$4,200, about 50-60% less than Neulasta's average of $8,700.
2. What factors influence biosimilar market share for Udenyca?
Physician prescribing habits, payer policies, hospital adoption, and regulatory guidance.
3. Will prices of biosimilars like Udenyca decrease further?
Yes, as more biosimilars enter and market competition intensifies, prices are projected to decline 10-25% over the next five years.
4. Where are regulatory policies most favorable for biosimilar growth?
Markets with strong mandates for biosimilar substitution and favorable reimbursement policies, especially in Europe and the U.S.
5. What is the likelihood of Udenyca capturing additional market share?
High likelihood, contingent on payer acceptance and physician prescribing patterns, especially as biosimilar confidence increases.
References
- IQVIA. (2022). Pharmaceutical Market Data.
- U.S. Food and Drug Administration. (2019). Udenyca (pegfilgrastim-jmdb) - FDA Approval Letter.
- EvaluatePharma. (2022). Global Biosimilars Market Report.
- Coherus Biosciences. (2019). Udenyca FDA approval announcement.
- Cohen, M. (2022). Biosimilars and market trends. Journal of Hematology, 45(3), 52–59.
