Last updated: February 25, 2026
What is NDC 57237-0222?
NDC 57237-0222 is the National Drug Code assigned to Rituximab (TRUXIMA), a biosimilar of Rituximab. It targets non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), and other autoimmune conditions.
Market Overview
Therapeutic Use and Market Size
- Rituximab is a monoclonal antibody used in oncology and autoimmune diseases.
- The global Rituximab market was valued at approximately USD 8.5 billion in 2022.
- Biosimilars like TRUXIMA target cost reductions in U.S. and European markets, capturing significant market share from originators.
Competitive Landscape
| Drug Name |
Brand Name |
Biosimilar to |
Year Approved |
Estimated Market Share (2022) |
| Rituximab |
Rituxan |
No |
1997 |
80% of total Rituximab sales |
| TRUXIMA |
Rituximab ABP |
Rituximab |
2018 (EU), 2019 (US) |
12% of Rituximab sales in US (2022) |
| Ruxience |
Rituximab-pvvr |
Rituximab |
2019 |
5% in US (2022) |
Regulatory Milestones
- FDA approval for TRUXIMA in 2019.
- European approval in 2017.
- Biosimilar uptake varies by region, with higher acceptance in Europe (due to earlier approval and cost incentives).
Price Projections
Current Pricing
| Region |
Estimated Wholesale Price (WAC) per Vial |
Notes |
| US |
USD 2,400 - USD 2,800 |
Variability by supplier |
| Europe |
EUR 1,900 - EUR 2,300 |
Competitive biosimilar prices |
Price Trends (2023-2030)
- Biosimilar prices are forecasted to decline by 10-15% annually, driven by increased competition and manufacturing efficiencies.
- Market penetration may reduce TRUXIMA’s price further, with projections indicating a USD 1,800 - USD 2,200 WAC per vial by 2030 in the US.
Price Comparison with Originator
| Product |
Approximate WAC per vial |
Year introduced |
Price decline since launch |
| Rituxan |
USD 4,500 |
1997 |
Stable with inflation; no significant decrease until biosimilar entry |
| TRUXIMA |
USD 2,400 |
2019 |
40-50% less than Rituxan at launch; further decrease expected |
Market Entry and Adoption Factors
- Pricing policies favor biosimilar adoption, especially after patent expiry.
- Physician preferences have historically shown resistance to biosimilars, but increasing comfort accelerates uptake.
- Reimbursement policies in the US and Europe heavily influence market penetration rates.
Risks and Opportunities
- Risks include delayed biosimilar acceptance, patent litigation, and regulatory changes.
- Opportunities exist in expanding indications, especially autoimmune diseases with growing prevalence.
Conclusions
- The U.S. market for Rituximab biosimilars is projected to grow at a compound annual growth rate (CAGR) of approximately 8% from 2023 to 2027.
- TRUXIMA’s price is expected to decline to the USD 1,800-2,200 WAC per vial range by 2030.
- Market share gains depend on competitive dynamics, physician acceptance, and reimbursement structures.
Key Takeaways
- NDC 57237-0222 (TRUXIMA) competes primarily in the oncology and autoimmune markets.
- The biosimilar has captured roughly 12% of Rituximab sales in the US as of 2022.
- Prices are falling, with projections indicating a further decrease over the next decade.
- Adoption barriers are decreasing as physicians become more familiar with biosimilars.
- Market expansion into autoimmune indications presents significant growth potential.
FAQs
Q1: When did TRUXIMA receive FDA approval?
A1: February 2019.
Q2: What is the main driver of biosimilar price declines?
A2: Increased competition and manufacturing efficiencies.
Q3: How much market share does TRUXIMA hold in the U.S.?
A3: Approximately 12% of Rituximab sales as of 2022.
Q4: What factors influence biosimilar adoption rates?
A4: Physician acceptance, reimbursement policies, and regulatory environment.
Q5: Which indications are expected to expand for TRUXIMA?
A5: Autoimmune diseases such as rheumatoid arthritis and vasculitis.
References
[1] IQVIA. (2023). Global Oncology Market Data.
[2] FDA. (2019). Approval Letter for Rituximab ABP (TRUXIMA).
[3] European Medicines Agency. (2017). TRUXIMA approval summary.
[4] EvaluatePharma. (2023). Biologic and Biosimilar Market Forecast.
