Last updated: February 28, 2026
What Is NDC 42291-0497?
NDC 42291-0497 refers to Udenyca (pegfilgrastim-cbqv), a biosimilar granulocyte colony-stimulating factor (G-CSF). Udenyca is indicated for prophylaxis of febrile neutropenia in patients undergoing myelosuppressive chemotherapy for certain cancers.
Market Overview
Industry Context
Udenyca entered a competitive G-CSF biosimilar market alongside US-originator Neulasta (pegfilgrastim). Biosimilars aim to reduce treatment costs, increasing access and influencing market dynamics.
Market Share and Adoption
- Initial launch (2018): Udenyca captured approximately 15% of the pegfilgrastim market by 2019.
- 2022 data: Udenyca's market share reached approximately 35%, driven by cost advantages over Neulasta.
- Reimbursement landscape: Medicare, Medicaid, and private insurers favor biosimilars when cost-effective.
Key Competitors
| Product |
Brand Name |
Manufacturer |
Price (per dose) |
Market Share (2022) |
| Pegfilgrastim (originator) |
Neulasta |
Amgen |
~$4,400 |
65% |
| Pegfilgrastim-cbqv |
Udenyca |
Pfizer |
~$3,300 |
35% |
Regulatory and Policy Environment
- FDA approval: Approved in 2018.
- CMS policies: Favor biosimilars to reduce costs.
- State Medicaid policies: Often require substitution of biosimilars when available.
Price Projections
Short-Term Price Trends (Next 1-2 Years)
- Stabilization period: Biosimilar prices tend to stabilize within 12-24 months post-launch.
- Current Price (2023): ~$3,300 per dose.
- Projected decline: 5-10% decrease over the next 2 years, driven by increased competition.
Mid- to Long-Term Price Trends (3-5 Years)
- Market penetration: Expected to reach 50-60% share.
- Pricing forecast: Biosimilar prices could decline to approximately $2,500-$2,900 per dose.
- Factors influencing price:
- Increased biosimilar approvals.
- Policy shifts favoring biosimilars.
- Manufacturer strategies for price erosion.
Factors Impacting Future Pricing
| Factor |
Impact |
| Entry of additional biosimilars |
Downward pressure due to increased options |
| Patent litigation timelines |
Delays in market entry for new competitors |
| Reimbursement policies |
Enhanced favorability for cost-effective agents |
| Manufacturer pricing strategies |
Potential for aggressive discounts |
Revenue and Cost Considerations
- Market revenue (2023): Assuming 300,000 doses annually at $3,300, the revenue is approximately $990 million.
- Cost of goods sold (COGS): Estimated at 20-30% of price, influencing profitability.
- Healthcare savings: Biosimilars potentially reduce chemotherapy-related hospitalization costs associated with febrile neutropenia.
Summary
Udenyca's market presence is growing within a landscape that favors biosimilar adoption. Current prices hover around $3,300, with expectations of slight declines driven by increased competition and policy shifts. Long-term prices may approach $2,500-$2,900 per dose as biosimilar market penetration deepens.
Key Takeaways
- Udenyca's market share increased from 15% to 35% over four years post-launch.
- Prices are forecasted to decline 5-10% over the next two years.
- The biosimilar landscape is expected to support further price erosion in the mid-term.
- Policy environment favors biosimilar adoption, influencing future pricing strategies.
- Revenue forecasts depend on continued market share growth and competitive pricing.
FAQs
1. How does Udenyca compare to the originator in terms of efficacy?
Udenyca has demonstrated comparable efficacy and safety to Neulasta in clinical trials, supporting its biosimilar approval and substitution potential.
2. What factors could accelerate price reductions?
Entry of additional biosimilars, policy changes favoring cost-savings, and increased payer rebates could all accelerate price declines.
3. How significant is market share potential for Udenyca?
Potential exists for Udenyca to reach 50-60% within five years, driven by cost advantages and prescriber acceptance.
4. Are there any legal or patent issues influencing pricing?
Patent litigations and exclusivity periods impact biosimilar market entry; current patents for Neulasta expire in 2023-2024, opening future opportunities.
5. What are the main barriers to biosimilar adoption?
Physician prescribing habits, rebate structures favoring originators, and regulatory hurdles can slow biosimilar uptake.
References
- U.S. Food and Drug Administration (FDA). (2018). Udenyca approval notice.
- IQVIA. (2022). Biosimilar Market Report.
- Centers for Medicare & Medicaid Services (CMS). (2022). Biosimilar policy updates.
- Drugs.com. (2023). Udenyca pricing and patient assistance.
- EvaluatePharma. (2022). Biosimilar industry outlook.
