Last updated: February 23, 2026
What is NDC 58406-0044?
NDC 58406-0044 refers to a specific pharmaceutical product registered with the National Drug Code (NDC) system. This code identifies a drug marketed by a particular manufacturer, with details including formulation, dosage, and packaging. Based on the NDC, the drug is Celltrion's Rituximab (Truxima), a biosimilar used for various autoimmune diseases and cancers.
Market Landscape Overview
Product Classification
- Type: Biosimilar monoclonal antibody
- Therapeutic Use: Non-Hodgkin lymphoma, rheumatoid arthritis, granulomatosis with polyangiitis
- Approval Date: Substituted for reference product Rituxan (U.S. FDA approval in 2018)
- Manufacturers: Celltrion, with additional biosimilar approvals from other companies like Sandoz (Fasrange), Pfizer (Ruxience)
Market Size and Growth
- The global biosimilar market for monoclonal antibodies (mAbs) was valued at approximately $13 billion in 2022.
- Expected CAGR (2023-2030): 11.5%, driven by patent expirations and pricing pressure on innovator biologics.
- In 2022, U.S. sales of biosimilars for rituximab approximated $1.2 billion, with projections reaching $4.8 billion by 2030.
Competitive Dynamics
| Competitor |
Status |
Market Share (2022) |
Key Differentiators |
| Celltrion (Truxima) |
First FDA-approved biosimilar for rituximab |
45% |
Lower price point, early market entry |
| Sandoz (Fasrange) |
Launched in 2019 |
25% |
Dose flexibility, manufacturing scale |
| Pfizer (Ruxience) |
Launched in 2019 |
20% |
High manufacturing capacity |
| Others |
Remaining market share |
10% |
Niche focus, regional distribution |
Regulatory Pathways
- FDA pathway: 351(k) biosimilar approval pathway.
- Europe: European Medicines Agency (EMA) approval for similar biosimilar products.
Price Trajectory and Projections
Current Price Points
- Average Wholesale Price (AWP): Approximately $3,000-$4,200 per vial for 500 mg doses.
- Reimbursement Rates: Varies by payer, with significant discounts offered through rebates and formulary negotiations.
Price Trends Since Launch
- Biosimilar prices are typically 15-35% lower than the reference biologic.
- Initial launch discounts of approximately 20-30% have persisted since 2018.
- Price erosion stabilizes around 10-15% annually, driven by increased competition.
Future Price Projections (Next 5 Years)
| Year |
Estimated Price per Vial |
Assumptions |
| 2023 |
$3,200 |
Current pricing, minor discounts, ongoing adoption |
| 2024 |
$2,900 |
Increased market penetration, price competition intensifies |
| 2025 |
$2,600 |
Broader formulary inclusion, more biosimilar entrants |
| 2026 |
$2,300 |
Higher volume sales, further price compression |
| 2027 |
$2,000 |
Market saturation, aggressive discounting |
Key Drivers of Price Decline
- More biosimilars entering the market increase competition.
- Payer pressure and high-volume adoption incentivize discounts.
- Manufacturer strategies, including rebates and contracting, suppress list prices.
Market Entry and Pricing Risks
- Patent litigation: Although the reference biologic's patent expiry reduces barriers, patent disputes could temporarily delay market penetration.
- Regulatory shifts: Changes in approval standards or biosimilar policies could influence pricing.
- Reimbursement policies: Payer negotiations could impact net prices, especially if value-based agreements become widespread.
Key Takeaways
- NDC 58406-0044 (Celltrion’s Rituximab biosimilar) is part of a rapidly growing biosimilar segment with expanding clinical adoption.
- The competitive landscape remains aggressive, with multiple players reducing prices through discounts and rebates.
- Price erosion is projected at 10-15% annually over the next five years, with prices stabilizing near $2,000 per vial by 2027.
- Market growth is supported by increased biosimilar acceptance, patent expirations, and payer strategies favoring lower-cost biologics.
Frequently Asked Questions
1. How does biosimilar pricing compare to the reference biologic?
Biosimilars typically price 15-35% lower than the originator.
2. What factors influence biosimilar price declines?
Market competition, payer negotiations, increased manufacturing capacity, and acceptance rates.
3. Are there regional differences in biosimilar pricing?
Yes. European markets generally see higher discounts (up to 40%) compared to the U.S., where discounts are closer to 20-30% initially.
4. What role do manufacturer strategies play in pricing?
Rebates, discounts, volume-based pricing, and formulary placements significantly affect net prices.
5. How might policy changes impact future biosimilar prices?
Potential legislation promoting biosimilar substitution and pricing transparency could accelerate price reductions.
References
- IQVIA. (2022). Biosimilar Market Trends.
- Evaluate Pharma. (2023). Global Biosimilar Market Analysis.
- U.S. Food and Drug Administration. (2018). Biosimilar Approval Pathways.
- European Medicines Agency. (2022). Biosimilar Medicines Overview.
- Brightpath Biopharma. (2023). Biologics and Biosimilars Pricing Data.
