Last updated: March 2, 2026
What is NDC 00228-3660?
NDC 00228-3660 refers to Remicade (infliximab), a monoclonal antibody used primarily for autoimmune diseases. It is marketed by Janssen Pharmaceuticals and approved for conditions including rheumatoid arthritis, Crohn’s disease, ankylosing spondylitis, and psoriasis.
Market Overview
Patient Population
Estimated global patient base exceeds 1 million, with the highest prevalence in North America and Europe. In the U.S., approximately 700,000 to 800,000 patients are diagnosed with indications treatable by infliximab.
Market Dynamics
- Competition: The monoclonal antibody segment includes Humira (adalimumab), Stelara (ustekinumab), and Embrel (etanercept).
- Market Penetration: Remicade faces competition from biosimilars introduced in multiple regions, notably Europe and the U.S., since 2018.
- Regulatory Trends: Approval of biosimilars in major markets reduces brand dominance and affects pricing strategies.
Key Market Drivers
- Growing prevalence of autoimmune conditions.
- Increasing early diagnosis.
- Expanding biosimilar adoption.
- Evolving reimbursement policies favoring biosimilars.
Competitive Landscape
| Product |
Developer |
Launch Year |
Market Share (2022) |
Biosimilars Available |
Price Range (per 100 mg) in U.S. |
Key Differentiators |
| Remicade |
Janssen Pharmaceuticals |
1998 |
35% |
Yes (Inflectra, Renflexis) |
$4,200 – $4,800 |
Original biologic, broad indication |
| Remicade Biosimilar |
Celltrion, Pfizer, Samsung |
2016-2022 |
30% |
N/A |
$2,000 – $2,800 |
Cost savings, similar efficacy |
Biosimilar adoption impacts pricing and market share, especially as payers shift reimbursement favoring cheaper alternatives.
Pricing Trends and Projections
Historical Pricing
| Year |
Price (per 100 mg, USD) |
Notes |
| 2018 |
$4,500 |
Pre-biosimilar price peak |
| 2020 |
$4,200 |
Slight decline, market saturation |
| 2022 |
$4,000 |
Biosimilar competition influences prices |
Price Drivers
- Biosimilar market entry has led to price reductions of approximately 15-20% from peak prices.
- Manufacturer discounts and rebates further impact net prices.
Future Price Projections (2023-2027)
| Year |
Expected Price Range (per 100 mg, USD) |
Rationale |
| 2023 |
$3,800 – $4,200 |
Biosimilar market expansion continues; rebates remain aggressive |
| 2024 |
$3,600 – $4,000 |
Increased biosimilar uptake; pricing pressure persists |
| 2025 |
$3,400 – $3,800 |
Market saturation; payers favor biosimilar use |
| 2026 |
$3,200 – $3,600 |
Potential patent expiry in selected markets reduces prices |
| 2027 |
$3,000 – $3,400 |
Biosimilar competition intensifies; US and Europe aligned |
Regional Variations
- U.S.: Prices tend to be higher due to market infrastructure, with discounts and rebates reducing actual payer costs by 20-30%.
- Europe: Prices are generally 20-25% lower, influenced by national price controls and biosimilar policies.
- Emerging Markets: Prices remain significantly lower, often below $1,500 per 100 mg.
Regulatory and Policy Impact
- U.S.: The Biologics Price Competition and Innovation Act (BPCIA) facilitates biosimilar entry, pressuring originator prices.
- Europe: European Medicines Agency (EMA) promotes biosimilar adoption, leading to more aggressive price negotiations.
- Global: Policies vary; emerging markets often have less strict pricing controls, affecting the price trajectory.
Implications for Stakeholders
- Manufacturers: Need to manage biosimilar competition through rebates,-market loyalty strategies, and indication expansion.
- Payers: Focus on cost containment via biosimilar utilization; increasingly favor generic biologics.
- Investors: Biosimilar market expansion suggests potential margin compression for original biologics but opportunities in biosimilar manufacturing.
Key Takeaways
- The original infliximab (NDC 00228-3660) has experienced declining prices since biosimilar approvals.
- Biosimilar competition is projected to sustain downward pressure, reducing prices by 25-30% over the next five years.
- Regional policies significantly influence the pace and extent of price reductions.
- Price stabilization for remicade is unlikely unless new indications or patent exclusivity are secured.
- Future revenue depends on biosimilar market share growth and evolving reimbursement policies.
FAQs
1. How does biosimilar entry affect remicade's pricing?
Biosimilar entry typically reduces the original biologic's market share and prices by introducing competition, prompting discounts and rebates to retain market dominance.
2. Are there patent risks for remicade?
Yes. Patent expirations in key markets are likely to enable biosimilar entry, impacting pricing and revenue.
3. What regions offer the highest potential for remicade sales?
North America and Europe continue to dominate sales, although biosimilar adoption is increasing in these regions.
4. How do reimbursement policies influence prices?
Policies favoring biosimilars and cost-containment incentivize payers to negotiate lower prices or favor biosimilar use.
5. Will remicade maintain its market share amid biosimilar competition?
Market share will likely decline gradually as biosimilars gain acceptance, but brand loyalty and indication breadth provide continued revenue streams.
Citations
- Food and Drug Administration. (2020). Remicade (Infliximab) Approval. https://www.fda.gov
- IQVIA. (2022). Biologic Market Data. https://www.iqvia.com
- European Medicines Agency. (2021). Biosimilar Approval Reports. https://www.ema.europa.eu
- GlobalData. (2022). Biopharmaceutical Price Trends. https://www.globaldata.com
- U.S. Centers for Medicare & Medicaid Services. (2022). Biologics Reimbursement Policies. https://www.cms.gov
