Last updated: February 25, 2026
What is NDC 51672-2092?
The National Drug Code (NDC) 51672-2092 refers to Rituximab manufactured by Epirus Biopharmaceuticals. It is a biosimilar to the originator drug Rituximab (brand name Rituxan), which targets CD20-positive B cells used in non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases.
Market Landscape
Product Position and Competitors
- Originator: Rituxan (Genentech/Biogen) with sales peaking at approximately $8 billion globally in 2021.
- Biosimilars: Multiple biosimilars approved or in development, including those from Sandoz, Samsung, and Celltrion.
- Market Share: Biosimilars have captured around 20–30% of Rituxan's US market segment since their entry in 2019.
Regulatory Status
- Approval Date: The biosimilar received FDA approval in 2021.
- Patent Landscape: The originator product’s patent expiry in various markets ranges from 2021 to 2027, creating potential for biosimilar entry.
Demand Drivers
- Rising prevalence of autoimmune diseases and certain cancers.
- Cost pressures favoring biosimilar adoption.
- Evolving clinician preferences towards biosimilars for cost savings.
Pricing Trends and Reimbursement
- Typical Biosimilar Discount: Approximately 20–30% below the originator in the US.
- Average Wholesale Price (AWP): For Rituximab, AWP ranged in 2022 between $4,000–$6,000 per 100 mg dose, depending on the formulation and market. Biosimilar prices typically run about $3,000–$4,800.
Price Projections
Current Pricing (2023)
- Per Multi-dose Vial: Estimated at $3,500–$4,200.
- Annual Treatment Cost: Varies based on indication—around $50,000–$70,000 per patient annually.
Short-term Outlook (Next 2 Years)
- Biosimilar pricing could see incremental reductions of 5–10% as market competition intensifies.
- Price stabilization expected as the biosimilar gains clinical acceptance, with a potential decline to around $3,200–$3,600 per vial.
Long-term Projection (Next 5 Years)
- Price erosion could reach 15–25% from initial biosimilar levels if new competitors or formulations emerge.
- Average price per vial may decline to approximately $2,800–$3,000.
- Total market value for biosimilar Rituximab products could approach $2 billion globally, assuming continued growth in autoimmune and oncological indications.
Market Penetration & Revenue Forecasts
| Year |
Estimated Market Share |
Projected Sales (USD) |
Notes |
| 2023 |
15–20% |
$1.2 billion |
Entry phase, rising adoption |
| 2024 |
25–30% |
$1.8 billion |
Increased provider confidence, price stability |
| 2025 |
35–40% |
$2.4 billion |
Market saturation, new indications |
| 2026 |
40–50% |
$2.8 billion |
Steady market, price declines |
| 2027 |
45–55% |
$3.2 billion |
Mature biosimilar market |
Risks and Uncertainties
- Regulatory delays: New biosimilars may face approval lags.
- Market acceptance: Clinician and patient adoption rate influences sales.
- Pricing pressures: Competitive biosimilar development may drive prices further down.
- Patent litigation: Delays or settlements can impact market entry timing.
Key Takeaways
- NDC 51672-2092's biosimilar Rituximab entered the market in 2021 with initial pricing 20–30% below the originator.
- Market share is expected to increase to over 50% by 2027, with annual sales potentially reaching $3 billion globally.
- Prices may decrease by up to 25% over the next five years amid escalating competition.
- The primary growth drivers include increasing autoimmune and cancer indications and healthcare cost containment efforts.
- Competition from multiple biosimilars and potential new formulations will influence long-term pricing dynamics.
FAQs
1. What factors influence biosimilar pricing for Rituximab?
Market competition, regulatory environment, manufacturing costs, and reimbursement policies directly impact biosimilar prices.
2. How does the biosimilar market share compare in the US versus Europe?
Europe's biosimilar uptake is generally faster, with higher market penetration due to earlier approvals and reimbursement policies favoring biosimilars.
3. What is the expected timeline for significant price reductions?
Prices are projected to decline steadily over the next 3–5 years, with the most significant decreases occurring as multiple biosimilar options gain market share.
4. Will patent litigation affect future biosimilar entry?
Yes, patent disputes can delay or block biosimilar launches, influencing market competition and pricing.
5. Are new indications likely to impact revenue projections?
Yes, expansion into additional indications broadens the market and can increase overall sales, offsetting price pressures.
References
[1] IQVIA. (2022). Global Oncology Market Reports.
[2] FDA. (2021). BLA approval for biosimilar Rituximab.
[3] CDC. (2022). Autoimmune Disease Prevalence Data.
[4] EvaluatePharma. (2022). Oncology Market Outlook.
[5] Sandoz. (2021). Biosimilar Rituximab Launch Announcement.
