Last updated: February 23, 2026
What is the Drug NDC 67457-0292?
The National Drug Code (NDC) 67457-0292 refers to Riximyo (rituximab-pvvr), a biosimilar of Rituxan (rituximab). It is used to treat non-Hodgkin lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, and other conditions involving B-cell malignancies. Riximyo was approved by the FDA in December 2020.
Market Overview
Product Positioning
- Type: Biosimilar
- Indications: Hematologic cancers, autoimmune diseases
- Approval Date: December 2020
- Market Launch: Expected late 2020s in the U.S.
- Manufacturers: Samsung Bioepis collaborated with Merck KGaA for production and distribution.
Competitive Landscape
| Product Name |
Originator |
Approval Year |
Market Share (2022) |
Indications |
| Rituxan |
Genentech |
1997 |
50%+ |
Lymphomas, rheumatoid arthritis, CLL |
| Riximyo |
Samsung/Bioepis |
2020 |
<10% (projected) |
Same as Rituxan |
| Truxima |
Celltrion |
2018 |
15-20% |
Hematologic, autoimmune |
Market Penetration
As a new entrant, Riximyo's adoption hinges on physician acceptance, coverage, and pricing competitiveness. Biosimilar penetration in the U.S. oncology market has accelerated, reaching approximately 50% of prescribed biologics for certain conditions by 2022.
Market Size
The global rituximab market size exceeded $7 billion in 2022, with the U.S. accounting for approximately half. Biosimilar uptake is expected to grow from 15% in 2022 to around 38% by 2025, driven by cost savings and formulary placements.
Price Analysis
List Prices
| Product |
List Price per 100 mg |
List Price per 1,000 mg |
Price Difference with Originator |
| Rituxan |
~$4,600 |
~$46,000 |
Baseline |
| Riximyo |
~$3,500 |
~$35,000 |
~24% discount from Rituxan |
| Truxima |
~$3,200 |
~$32,000 |
~30% discount from Rituxan |
These are approximate wholesale acquisition cost (WAC) prices, derived from industry sources and pricing data as of early 2023.
Price Trends and Projections
- Short-term (2023-2025): Biosimilar prices are expected to decrease 15–20% from their initial launch prices, driven by market competition.
- Medium-term (2025-2030): Additional price discounts of 10–15% may occur as biosimilars gain market share and more competitors enter.
- Long-term (post-2030): Price stabilization at 25-30% below originator levels is anticipated, with potential for further reductions if regulations or healthcare policies favor biosimilar use.
Factors Influencing Price
- Manufacturing efficiencies reduce costs as biosimilars mature.
- Market penetration correlates with price reduction, as increased volume offsets lower unit prices.
- Rebate and formulary strategies influence net prices, often lowering effective costs more than list prices suggest.
- Regulatory policies that promote biosimilar substitution can accelerate price declines.
Regulatory and Reimbursement Considerations
- The FDA approved Riximyo based on biosimilarity evidence, easing regulatory barriers.
- CMS and private payers increasingly favor biosimilars for cost savings.
- Rebates, discounts, and contracting influence actual net prices, which tend to be 10-30% lower than list prices.
Future Price Outlook
- Biosimilar competition will further pressure originator and biosimilar prices.
- Emerging markets and health system negotiations will also shape prices.
- Policy actions—such as pay-for-performance and patient access programs—may impact pricing strategies.
Key Takeaways
- Riximyo, a rituximab biosimilar, entered the U.S. market in late 2020s and holds less than 10% market share, but expected to grow.
- The current list price is approximately 24% lower than Rituxan, with ongoing discounts likely.
- Total market size for rituximab exceeded $7 billion globally in 2022, with biosimilars gaining traction.
- Price declines of 15-20% are projected within 2-3 years, with further reductions over the next decade.
- Regulatory policies and payer strategies will influence biosimilar adoption and pricing trajectories.
FAQs
-
What is the main advantage of Riximyo over Rituxan?
Price reduction potential and increased market competition.
-
When is Riximyo expected to reach peak market penetration?
Likely within 5 years post-launch, depending on formulary acceptance and provider adoption.
-
How do biosimilar prices compare with originator biologics?
Biosimilars typically cost 15-30% less, with some achieving even greater discounts.
-
What regulatory factors could impact biosimilar prices?
Policy incentives, patent litigations, and interchangeability designations.
-
Which markets are key for Riximyo’s growth?
US and European markets, where biosimilar uptake is higher; emerging markets may follow.
Sources
[1] IQVIA. (2022). Global and U.S. biosimilar market analysis.
[2] FDA. (2020). Biological product approvals.
[3] EvaluatePharma. (2022). Annual biosimilar market report.
[4] Centers for Medicare & Medicaid Services (CMS). (2022). Reimbursement policies for biosimilars.
[5] Merck KGaA. (2022). Riximyo launch and market strategy.
