Last updated: February 21, 2026
What Is the Nature of the Drug Identified by NDC 60505-4852?
NDC 60505-4852 refers to a specific pharmaceutical product. Based on publicly available data, it is identified as Udenyca (pegfilgrastim-cbqv), a biosimilar to Neulasta (pegfilgrastim). Udenyca is used to reduce the incidence of febrile neutropenia in patients receiving myelosuppressive chemotherapy.
Key Characteristics:
- Formulation: Subcutaneous injection
- Dosage Strength: 6 mg/0.6 mL
- Approval Date: February 2019 by FDA
- Manufacture: Coherus BioSciences
Market Overview
Market Size
The neutropenia growth factor market is driven by chemotherapy treatment prevalence. The primary target patient population includes adult cancer patients undergoing cytotoxic chemotherapy.
- Market Value (2022): Estimated at $1.2 billion globally
- Market Growth Rate: 4-6% annually (Was previously driven by increasing chemotherapy usage)
Competitive Landscape
- Main Competitors: Neulasta (Amgen), Fulphila (Mylan/Biocon), Udemyca (Coherus), and other biosimilars
- Market Share (2022): Udenyca held approximately 15% of the U.S. biosimilar pegfilgrastim market
Pricing Trends
- Original nephrolysis (Neulasta): Approximate retail price $5,000 per dose
- Biosimilar Udenyca (2019): Initially priced 15-25% lower (~$3,800–$4,250)
- Post-launch discounts and negotiations lowered effective prices further in practice.
Price Projections
Current Pricing
- List Price (2023): Around $4,500–$4,800 per dose (per rebate-adjusted estimates)
- Reimbursement Cost: Approximately $3,200–$3,700 after negotiations
Short-term (1-2 years)
- Projected Price Range: Stable between $4,300 and $4,800 per dose
- Rationale: Limited biosimilar entry, price stability in established contracts, and sustained demand
Mid-term (3-5 years)
- Projection: Prices may decline gradually to $4,000–$4,300 per dose
- Factors Influencing Prices:
- Increased biosimilar competition from new entrants
- Cost-saving measures in healthcare systems
- Potential patent litigations or exclusivity periods ending
Long-term (5+ years)
- Projection: Possible further reduction to $3,500–$4,000
- Conditions: Entry of more biosimilars, patent expirations of reference products, and market shifts toward lower-cost generics
Key Market Drivers and Barriers
Drivers
- Growing incidence of cancer globally
- Adoption of biosimilars driven by cost-effectiveness
- Expanding indications for pegfilgrastim
Barriers
- Physician and patient familiarity with originator drugs
- Regulatory and patent barriers in certain markets
- Price sensitivity in different healthcare settings
Regulatory and Policy Impact
- FDA Approvals: Facilitates biosimilar entry
- CMS and Payer Policies: Favor biosimilars to reduce costs
- International Markets: Regulatory approval varies; price points depend on local healthcare economics
Conclusion
Udenyca's market remains competitive with a stable pricing trend amid ongoing biosimilar competition. Price reductions are likely over the next 3–5 years, contingent upon market dynamics, biosimilar approvals, and healthcare system negotiations.
Key Takeaways
- NDC 60505-4852 (Udenyca) is a pegfilgrastim biosimilar with a market size around $1.2 billion globally.
- Current list prices hover near $4,800 per dose, with post-rebate reimbursement closer to $3,200–$3,700.
- Prices are expected to decline gradually over the next 3–5 years due to increased biosimilar competition.
- Cost reductions will be driven by new biosimilar entries, healthcare policy shifts, and patent expirations.
- Market growth relies on rising chemotherapy use and continuing acceptance of biosimilars.
FAQs
1. What are the main factors influencing biosimilar prices?
Market competition, payer negotiations, manufacturing costs, and regulatory policies primarily drive biosimilar prices.
2. How does Udenyca compare to the original Neulasta in terms of cost?
Udenyca is generally priced 15-25% lower than Neulasta initially but can vary based on contracts and discounts.
3. Are new biosimilars expected to enter the pegfilgrastim market soon?
Yes, patents for original drugs are expiring; several biosimilars are in development or pending approval globally.
4. How do healthcare policies affect biosimilar adoption?
Policies favoring cost containment encourage biosimilar use, potentially lowering prices further.
5. What is the outlook for pricing in international markets?
Pricing varies significantly depending on local regulatory approval, reimbursement models, and healthcare budgets.
References
[1] FDA. (2019). Udenyca (pegfilgrastim-cbqv) approval letter.
[2] EvaluatePharma. (2022). Biosimilar pegfilgrastim market report.
[3] IQVIA. (2022). Global oncology market analysis.
[4] Amgen. (2022). Neulasta product details.
[5] Coherus BioSciences. (2019). Udenyca product overview.
