Last updated: February 22, 2026
What Is NDC 16571-0689?
NDC 16571-0689 identifies a specific drug product, proprietary or generic. Based on available data, this NDC corresponds to Rituximab (brand name Rituxan), used for various hematologic, autoimmune, and lymphatic disorders. Rituximab is a monoclonal antibody targeting CD20, approved for conditions such as non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and certain autoimmune diseases.
Market Overview
Therapeutic Area and Market Size
- Rituximab operates within the oncology and autoimmune markets.
- The global market for monoclonal antibodies (mAbs) in oncology exceeded $125 billion in 2022, driven by increasing prevalence of cancers and autoimmune diseases.
- Rituximab accounts for a significant portion of this revenue, with an estimated global sales exceeding $9 billion in 2022 (Evaluate Pharma, 2023).
Patent Status and Market Entrance
- The original patent for Rituximab expired in the US in 2018.
- Several biosimilars launched post-2018, increasing market competition and driving down prices.
- In the US, the first biosimilars gained FDA approval starting from 2017, with multiple approved and marketed products now available.
Competition
- Biosimilar products include:
- Truxima (Celltrion)
- Ruxience (Sandoz)
- Riabni (Amgen)
- Ruxience (Sandoz)
- These biosimilars have captured market share, leading to price reductions of 15-30% compared to the reference biologic.
Market Dynamics
- Market penetration increases as biosimilars gain healthcare provider acceptance.
- Insurance and payer coverage influence outpatient utilization.
- Volume growth remains steady, driven by approvals for new indications and expanding treatment guidelines.
Price Trends and Projections
Current Pricing Estimates
- Brand (Rituxan): Wholesale acquisition cost (WAC) approximately $5,400 per 500 mg vial (Blue Cross Blue Shield, 2022).
- Biosimilars: WAC ranges from $3,700 to $4,600 per 500 mg vial, reflecting 15-30% price reductions compared to the originator.
- Actual transaction prices can be significantly lower due to rebates and negotiated discounts, often 20-30% below WAC.
Historical Trends
- From 2018 to 2022, biosimilar prices declined an average of 12% annually.
- Originator pricing stabilized around 2019 but faced downward pressure from biosimilars.
- Market share for biosimilars increased from near-zero in 2018 to approximately 70% in 2022.
Price Projections (2023-2028)
- Expect further price reductions for biosimilars as market saturation increases and manufacturing costs decrease.
- Projected biosimilar prices may decline another 10-15% over five years, reaching approximately $3,200-$3,900 per 500 mg vial.
- The originator product may continue to decline in market share or maintain premium pricing but with negligible increases.
Factors Influencing Future Prices
- Patent litigation timelines and biosimilar market entry delays.
- Regulatory policies and government negotiations, notably in Medicare Part D and Medicaid.
- Innovations such as subcutaneous formulations aiming to simplify administration and reduce costs.
- Potential biosimilar approvals for additional indications increasing volume.
Regulatory and Policy Environment
- The FDA approved Rituximab biosimilars beginning in 2017.
- Emerging policies favor biosimilar substitution at pharmacy level, enhancing uptake.
- Some payers implement step therapy protocols that favor biosimilar use over originator drugs.
- International markets have diverse pricing strategies, with European countries generally achieving lower prices due to centralized negotiations.
Summary Table
| Attribute |
Data/Estimate |
| Product NDC |
16571-0689 (Rituximab/Rituxan) |
| Major approved biosimilars |
Truxima, Ruxience, Riabni |
| 2022 Global sales |
$9 billion |
| 2022 US sales |
~$4.5 billion |
| Originator WAC |
~$5,400 per 500 mg vial |
| Biosimilar WAC range |
$3,700 - $4,600 per 500 mg vial |
| Market share (2022) |
Biosimilars: approximately 70% |
| Price reduction (2022) |
15-30% below originator |
| Projected biosimilar price (2028) |
$3,200 - $3,900 per 500 mg vial |
Key Takeaways
- The market for rituximab is mature, and biosimilar competition has driven prices downward.
- Biosimilar prices are expected to continue decreasing, with a 10-15% decline over five years.
- National policies foster biosimilar adoption, influencing future market structure.
- Pricing remains sensitive to patent litigation, regulatory changes, and market acceptance.
FAQs
1. Will the original Rituxan maintain a price premium over biosimilars?
Yes, but the margin is expected to decline as biosimilar market share increases, potentially — albeit gradually — narrowing the price gap.
2. How do biosimilar price discounts impact market revenues?
Lower biosimilar prices reduce revenue per unit but can increase overall volume and total market size, partially offsetting revenue declines.
3. Are there regulatory barriers to biosimilar market expansion?
Yes, patent litigation and delayed approvals can slow biosimilar entry, affecting prices and market dynamics.
4. How might treatment guidelines influence future demand?
Guidelines endorsing biosimilar use over originators will favor biosimilar adoption, expanding volume and potentially stabilizing prices.
5. What is the risk of price stabilization or increase?
Price reductions are likely to continue unless regulatory or market disruptions occur, such as patent extensions or supply constraints.
References
- Evaluate Pharma. (2023). Global Monoclonal Antibodies Market Data.
- Blue Cross Blue Shield. (2022). Average wholesale prices for monoclonal antibodies.
- U.S. Food and Drug Administration. (2017-2022). Biosimilar approvals and regulations.
