Last updated: March 5, 2026
What Is the Drug According to NDC 00574-2008?
The National Drug Code (NDC) 00574-2008 corresponds to Biosimilar Remicade (Infliximab) for Injection, including the biosimilar versions. It is primarily used to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, and psoriasis.
Market Context and Product Details
Product Classification
- Name: Infliximab (biosimilar version)
- Therapeutic Area: Autoimmune and inflammatory diseases
- Formulation: Intravenous infusion
- Brand Equivalent: Remicade (original biologic by Janssen)
Regulatory Status
- Several biosimilar infliximabs licensed by FDA since 2016
- Marketed biosimilars include:
- Inflectra (Pfizer)
- Renflexis (Samsung Bioepis)
- Ixifi (Sandoz)
Market Penetration
- Biosimilars have gained approval and market share, reducing prices of the original biologic.
- Estimated biosimilar market share (2022): Approximately 65% of infliximab prescriptions in the U.S.[1]
Market Size and Trends
| Year |
U.S. Market Size (USD millions) |
CAGR (2018-2022) |
Notes |
| 2018 |
1,800 |
— |
Original infliximab held dominant share |
| 2019 |
2,050 |
12% |
Biosimilar entry increases competition |
| 2020 |
2,300 |
11% |
Accelerated biosimilar utilization |
| 2021 |
2,600 |
13% |
Biosimilar prescriptions surpass original biologic |
| 2022 |
2,950 |
13.5% |
Biosimilar market share stabilizes at ~65% in the U.S. |
Global Market
- Estimated global infliximab market (2022): USD 3.5 billion
- Projected CAGR (2022-2028): 7.5%[2]
Price Projections
Current Pricing Landscape
- Brand Remicade (per 100 mg): USD 2,800 – 3,200 (wholesale acquisition cost, WAC)
- Biosimilar Inflximab (per 100 mg): USD 1,300 – 1,600
- Price discounts compare to the original biologic in the range of 40-55%
Future Price Trends
- Biosimilars expected to continue exert downward pressure.
- Projected average price decrease for biosimilars (2023-2028): 15-20%
- Implications:
- Biosimilar prices could stabilize near USD 1,100 - 1,300 per 100 mg by 2028.
- Original biologic prices may decline, although at a slower rate.
Cost Savings and Market Dynamics
- Payers increasingly favor biosimilars, pressuring list prices downward.
- Increased biosimilar adoption could lead to cost reductions of USD 1 billion annually in the U.S. healthcare system.
Key Factors Influencing Market and Price
- Regulatory Approvals: Biosimilar approval pathways, patents, and exclusivity window expiry.
- Market Competition: Number of biosimilar entrants affects pricing.
- Physician and Patient Acceptance: Prescribing behaviors impact biosimilar uptake.
- Pharmacovigilance: Long-term safety data influence confidence and adoption.
- Healthcare Policies: Reimbursement policies incentivize biosimilar use.
Key Dates and Milestones
- 2016: First biosimilar infliximab approved in the U.S.
- 2018-2020: Increasing biosimilar approvals and market adoption.
- 2022: Biosimilars capturing approximately 65% of infliximab prescriptions in the U.S.
- 2023-2028: Continued market penetration and price adjustments.
Summary
The NDC 00574-2008 refers to biosimilar infliximab formulations gaining market share due to policy shifts and cost pressures. The market is projected to grow at a 7.5% CAGR globally, with domestic prices expected to decline by 15-20% through 2028. The overall trend favors increased biosimilar volume, driven by stability in pricing, payer incentives, and regulatory support.
Key Takeaways
- Biosimilar infliximab will account for the majority of infliximab prescriptions in the U.S. by 2028.
- Prices for biosimilars are projected to decrease by 15-20%, contributing to substantial healthcare savings.
- Continued competition and regulatory momentum will influence market dynamics.
- Biosimilar market penetration is stabilizing but remains sensitive to regulatory and policy shifts.
- International markets follow similar trends, with notable growth in Europe and Asia.
FAQs
1. How quickly is biosimilar infliximab gaining market share?
By 2022, biosimilars hold approximately 65% of infliximab prescriptions in the U.S., a rapid increase since 2016.
2. What factors could slow biosimilar price declines?
Delayed regulatory approvals, patent litigations, or limited physician acceptance can impede price reductions.
3. Will original biologics maintain premium pricing?
Pricing may decline gradually but generally remains higher than biosimilars due to brand loyalty and perceived safety.
4. How does biosimilar market growth impact healthcare costs?
It reduces costs by lowering drug prices and increasing access to biologic therapies.
5. Are biosimilar infliximabs interchangeable in clinical practice?
Interchangeability varies by state and insurer policies; FDA has designated some biosimilars as interchangeable.
References
- IQVIA. (2022). Biosimilars Market Report.
- GlobalData. (2023). Infliximab Market Forecast.
