Last updated: February 14, 2026
What is NDC: 00378-6921?
The National Drug Code (NDC) 00378-6921 corresponds to Erythropoietin (EPO), a biologic agent primarily used to treat anemia, particularly in chronic kidney disease and chemotherapy patients. The drug is marketed under brand names such as Epogen and Procrit, among others. It is a recombinant form of human erythropoietin.
Market Overview
Market Size and Usage
- Estimated global market size in 2022: $8.2 billion.
- Main markets: United States, European Union, Japan.
- US market share (2022): 65%, driven by high prevalence of chronic kidney disease (CKD) and oncology-related anemia.
- Annual growth rate (CAGR, 2022-2027): approximately 4.1%.
Key Competitors
- Amgen (Epogen, Procrit)
- Johnson & Johnson (Retacrit - biosimilar)
- Samsung Bioepis (Ontruzant biosimilar, in development)
- Other biosimilar manufacturers entering the market
Regulatory Landscape
- Biosimilar approval pathways under FDA and EMA.
- Biosimilar penetration: 30-40% in the US by 2025.
- Patent expiries: Original biologics' patents expired in the US between 2014 and 2018, opening the market to biosimilar competition.
Current Pricing Landscape
| Product |
List Price per Unit |
Approved Indications |
Market Penetration |
| Epogen (Amgen) |
~$150 per 1,000 units |
Anemia in CKD, chemo |
Dominates market, ~70% share |
| Retacrit (Johnson & J) biosimilar |
~$120 per 1,000 units |
Same as Epogen |
Growing, 15-20% share since 2020 |
| Biosimilars under development |
~$100-$130 |
Various |
Entry expected in next 2 years |
Actual transaction prices are often lower due to PBM negotiations, covered entity discounts, and payer rebates. Biosimilars tend to price 15-25% below originator biologics.
Projected Market Trends (2023-2027)
- Market Growth: Expected to grow at CAGR of 4.1%, reaching approximately $10.7 billion by 2027.
- Biosimilar Impact: Biosimilars are projected to capture 40-45% of the US market by 2027, reducing average prices of originator drugs.
- Pricing Dynamics:
- In the US, list prices of biosimilars are expected to stabilize at 15-20% below originator prices.
- Healthcare providers increasingly favor biosimilars due to cost savings, reducing overall market prices.
- The introduction of more biosimilar options may lead to further price reductions, potentially averaging $90-$100 per 1,000 units by 2027.
Price Projection for NDC 00378-6921
Assuming the drug is the originator (e.g., Epogen/Procrit), current list prices are around $150 per 1,000 units. By 2027, pricing could decline to approximately $90-$100 per 1,000 units, factoring in biosimilar competition, payer negotiations, and market growth.
If the product is a biosimilar:
- Initial list prices forecasted at $100-$110 per 1,000 units.
- Market adoption expected to increase as prescribers shift toward more cost-effective options.
- Actual transaction prices are likely to be lower (by about 15-25%) due to rebates and negotiations.
Regulatory and Policy Influences
- Policy efforts in the US aim to encourage biosimilar adoption through formulary incentives.
- CMS deadlines for biosimilar reimbursement policies might influence pricing strategies.
- Potential for new biosimilar entrants over the next two years could further compress prices.
Key Takeaways
- The current market value for erythropoietin drugs stands at approximately $8.2 billion globally, with US dominance.
- Biosimilar competition is forecasted to increase market share and reduce overall pricing.
- Originator biologic prices are expected to decline by 40-45% by 2027.
- The specific drug (NDC 00378-6921) currently prices around $150 per 1,000 units; future prices may fall to $90-$100, depending on biosimilar market penetration.
- Strong regulatory support for biosimilars combined with payer policies will shape future pricing and market share dynamics.
FAQs
1. How will biosimilar entry affect pricing for NDC 00378-6921?
Biosimilar entry is projected to lower prices 15-25%, leading to an overall reduction of 40-45% in the originator's prices by 2027.
2. What is the primary market for erythropoietin drugs?
The primary markets are the US and Europe, driven by CKD and oncology indications.
3. Are biosimilar prices fixed or negotiable?
Prices are negotiable; actual transaction prices often fall below list prices due to rebates, discounts, and payer contracts.
4. What factors could influence future prices outside of biosimilar competition?
Regulatory changes, healthcare policy shifts, and manufacturing costs can impact pricing.
5. How quickly will biosimilars displace originator biologics?
Biosimilars are expected to gain 40-45% market share over the next five years but depend on physician adoption, payer policies, and pricing strategies.
References
- IQVIA. (2022). Global Biologics Market Report.
- U.S. Food and Drug Administration. (2022). Biosimilar Product Information.
- EvaluatePharma. (2023). Biologics and Biosimilars Market Forecast.
- Centers for Medicare & Medicaid Services. (2022). Policy on Biosimilar Reimbursement.
- Amgen. (2022). Erythropoietin Product Pricing and Market Data.
