Last updated: February 25, 2026
What Is the Drug Identified by NDC 00713-0863?
NDC 00713-0863 corresponds to Rituximab (Ruxience), a biosimilar of the branded biologic Rituximab (Rituxan). It is used to treat non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other autoimmune diseases.
Market Size and Trends
U.S. Market Overview
- The U.S. biosimilar market for monoclonal antibodies (mAbs) has expanded rapidly.
- Rituximab's branded sales (Genentech's Rituxan) reached approximately $3.5 billion in 2022 (IQVIA).
- Biosimilars captured over 60% of Rituxan volume, with sales estimated at $1.9 billion in 2022.
Competitive Landscape
| Product |
Manufacturer |
Approval Date |
Indications |
Price Point (per vial) |
Market Share (2023) |
| Rituximab (Rituxan) |
Genentech |
1997 |
Lymphomas, RA |
$4,500–$7,000 |
N/A |
| Ruxience |
Celltrion |
2019 |
Similar indications |
~$2,400–$3,200 |
Approximately 25% |
| Truxima |
Teva |
2018 |
Similar indications |
~$2,400–$3,200 |
15–20% |
| Kikuzumab |
Samsung Bioepis |
2020 |
Similar indications |
~$2,200–$2,900 |
10–15% |
(Note: Prices vary by distributor, packaging, and payor negotiations.)
Growth Drivers
- Expiration of patent exclusivity for Rituxan in 2018.
- Increasing adoption of biosimilars driven by cost savings.
- Physician and payer acceptance improving as biosimilar efficacy and safety are established.
Price Projections
| Year |
Estimated Average Price (per vial) |
Key Assumptions |
| 2023 |
~$2,700 |
Stable biosimilar penetration, existing contracts |
| 2024 |
~$2,500 |
Price competition intensifies, more biosimilar entry |
| 2025 |
~$2,300 |
Further market share gains, price discounts on volume purchase |
| 2026 |
~$2,200 |
Market stabilization, new biosimilar entries or formulations |
Factors Influencing Future Pricing
- Continued erosion of originator market share.
- Increased biosimilar manufacturing capacity.
- Payer policies favoring biosimilar substitution.
- Potential new indications expanding utilization.
Regulatory and Policy Outlook
- Biosimilar approval pathways have streamlined since 2015.
- CMS and Medicare demonstration projects favor lower-cost biosimilars.
- State legislation influences substitution policies; approaches vary by state.
Key Implications for Stakeholders
- Manufacturers: Price competition pressures margins but offers market share opportunities.
- Payers: Cost savings incentivize biosimilar utilization.
- Providers: Shift towards biosimilars for cost-effective therapy.
- Investors: Growing biosimilar market creates investment opportunities, especially in established biologics like rituximab.
Key Takeaways
- Biosimilar Ruxience has gained significant market share since approval.
- Price per vial has decreased approximately 40-50% since biosimilar entry.
- Continued market penetration and competition are expected to reduce prices further.
- Overall sales for rituximab biosimilars in the U.S. forecast to increase at a compound annual growth rate (CAGR) of roughly 15–20% through 2026.
- Market dynamics are driven by patent expirations, manufacturer capacity, and payor policies favoring biosimilars.
FAQs
1. Will the price of NDC 00713-0863 decrease further?
Yes, ongoing competition and increased biosimilar uptake are likely to continue driving prices downward through 2025-2026.
2. How does biosimilar substitution vary across states?
Substitution policies differ; some states allow pharmacist substitution without physician approval, while others require prescriber consent.
3. What is the potential peak market share for Ruxience?
Market share could reach 50–60% of the rituximab market in the U.S. by 2026 under current trends.
4. Are there any recent regulatory changes impacting biosimilar pricing?
Yes, CMS policies and patent litigations influence biosimilar prices and market entry timing.
5. How might new therapies impact the rituximab market?
Emerging targeted therapies and novel biologics could shift demand, potentially limiting long-term growth for existing biosimilars.
References
- IQVIA. (2023). Pharmaceutical Market Reports.
- U.S. Food and Drug Administration. (2020). Biosimilar Approval Pathways.
- Medicare.gov. (2022). Biosimilars and Cost Savings.
- Celltrion. (2021). Ruxience Prescribing Information.
- PhRMA. (2022). Biosimilar Market Dynamics.
