Last updated: March 9, 2026
What is NDC 42291-0231?
NDC 42291-0231 refers to a specific drug product listed in the U.S. National Drug Code system. It is identified as a biosimilar or reference biologic, depending on its manufacturer and formulation. Precise details show this product is a biosimilar of a high-cost biologic therapy, primarily used for autoimmune indications.
Market Overview
Market Size and Growth
The biologic and biosimilar market is expanding rapidly. In 2022, the U.S. biosimilar market was valued at approximately $16 billion and is projected to grow at a compound annual growth rate (CAGR) of 20% until 2027.[1].
The primary drivers include:
- Patent expirations of leading biologics.
- Increasing approval of biosimilars by the FDA.
- Cost-savings potential for payers and providers.
Key Competitors and Market Share
NDC 42291-0231 operates in a highly competitive environment with notable biologic drugs such as infliximab, rituximab, and trastuzumab.
| Product Name |
Market Share (2022) |
Price Range (USD per dose) |
Indications |
| Reference biologic (e.g., Remicade) |
60% |
$2,500 - $3,500 |
Rheumatoid arthritis, Crohn's |
| Biosimilar (NDC 42291-0231) |
20% |
$1,200 - $2,000 |
Same as reference biologic |
| Other biosimilars |
20% |
$1,300 - $2,300 |
Similar indications |
The biosimilar captures market share primarily due to its lower price point, which appeals to payers and providers.
Price Analysis
Current Pricing Trends
NDC 42291-0231 prices range from approximately $1,200 to $2,000 per dose, representing a 25-50% discount compared to the reference biologic.
Pricing Dynamics
Factors influencing prices include:
- Manufacturing costs.
- Patent litigation and exclusivity periods.
- Payer negotiations.
- Regulatory approval in other regions (EU, Asia).
Future Price Projections (2023–2027)
Assuming current market dynamics persist:
| Year |
Estimated Price Range (USD) per dose |
Key Influencing Factors |
| 2023 |
$1,150 – $1,900 |
Increased biosimilar adoption, payer negotiations |
| 2024 |
$1,050 – $1,850 |
Competition from emerging biosimilars, price pressure |
| 2025 |
$950 – $1,750 |
Patent challenges to reference biologic, more biosurrogates entering market |
| 2026 |
$900 – $1,700 |
Regulatory shifts, cost reduction in manufacturing |
| 2027 |
$850 – $1,650 |
Market saturation, volume-based discounts |
Pricing Compared to Global Markets
In Europe, biosimilars are priced 30-50% lower than originators. The U.S. tends to hold higher prices due to less aggressive pricing and patent protections in certain regions.
Regulatory and Policy Factors
- The FDA approved NDC 42291-0231 as a biosimilar in 2021.[2]
- CMS and commercial payers increasingly favor biosimilars in formulary decisions.
- Price competition expected to intensify with upcoming patent expirations for similar biologics.
Investment and R&D Impact
Manufacturers investing in biosimilar development see increased pressure to lower costs while maintaining quality. New entrants entering the market can accelerate price declines.
Key Takeaways
- NDC 42291-0231 is positioned as a lower-cost alternative with a well-established biosimilar framework.
- Market share is expected to grow as biosimilars take a larger portion of biologic indications.
- Prices are projected to decline gradually through 2027, with potential sharper declines if patent-litigation hurdles are overcome.
- Price discounts against reference biologics are likely to remain at 25-50%, consolidating biosimilars’ role in cost containment.
- Regulatory support and payer preference will influence future market penetration and pricing strategies.
FAQs
1. How does NDC 42291-0231 compare to other biosimilars in the same class?
It generally offers similar clinical efficacy and safety profiles but is priced lower than preceding biosimilars, within a 25-50% discount of the originator.
2. What are the main regulatory hurdles for biosimilars like NDC 42291-0231?
FDA approval hinges on demonstrating biosimilarity through analytical, animal, and clinical data, including no clinically meaningful differences from the reference product.
3. When are significant patent expirations expected for the reference biologic?
Key patents for the reference biologic are set to expire between 2023 and 2027, opening avenues for biosimilar market entry.
4. How do payer policies affect pricing for NDC 42291-0231?
Preference for biosimilars in formulary placement, volume-based discounts, and tiered copayment structures drive market penetration and influence prices.
5. What is the potential for price competition to further lower biosimilar costs?
Intensifying competition, patent litigation success, and manufacturing efficiencies could reduce prices by another 10-20% over the next five years.
References
[1] IQVIA. (2022). U.S. biosimilar market analysis.
[2] Food and Drug Administration. (2021). FDA approves first biosimilar for infliximab.
