Last updated: March 1, 2026
What Is NDC 63481-0628?
NDC 63481-0628 is a drug product identified as Infliximab (Remicade). It is a biologic therapy used primarily to treat autoimmune conditions such as rheumatoid arthritis, Crohn’s disease, and ulcerative colitis. The product is supplied by Pfizer Inc.
Market Size and Revenue
Current Market Landscape
- Global biologic infliximab market (2022): Estimated at approximately $10 billion.
- U.S. infliximab market (2022): Around $3.5 billion.
- Market growth rate: 7.2% CAGR projected through 2028.
Key Competition
- Originator: Remicade (Pfizer)
- Biosimilars launched in 2018 and 2020, including:
- Celltrion's Remsima
- Samsung Bioepis’ Renflexis
- Sandoz’s Inflectra
Revenue Trends
| Year |
Remicade (Pfizer) |
Biosimilars (aggregate) |
Total Market |
| 2020 |
$3.8 billion |
$0.4 billion |
$4.2 billion |
| 2022 |
$3.5 billion |
$0.9 billion |
$4.4 billion |
| 2024* |
$3.2 billion |
$1.5 billion |
$4.7 billion |
*(Estimate based on CAGR)
Price Dynamics and Projections
Base Price (U.S. List Price)
- Remicade (2018-2022): Approximate list price per vial increased from $600 to $850.
- Biosimilars: Priced 15-25% lower than the originator.
Pricing Trends
- Remicade: Has experienced modest annual list price increases averaging 3-4% per year post-2018.
- Biosimilar Entry: Initiated price competition, reducing originator revenue margins.
Price Projections (2023-2027)
| Year |
Remicade (Pfizer) |
Biosimilars |
Effective Average Price (per vial) |
| 2023 |
~$870 |
~$680 |
$730 |
| 2025 |
~$900 |
~$670 |
$700 |
| 2027 |
~$930 |
~$650 |
$690 |
Originator prices will likely continue gradual increases, constrained by biosimilar competition and payer pressure. Biosimilar prices are expected to decline further as more competitors enter and volume increases.
Regulatory and Market Entry Barriers
- Patent protections for Remicade extended until at least 2025, limiting biosimilar market penetration.
- Several biosimilar approvals obtained, but market share dominance remains with the originator.
- Payer policies favor biosimilars, encouraging substitution to reduce costs.
Key Market Drivers
- Increasing prevalence of autoimmune diseases.
- Growing adoption of biosimilars driven by cost savings.
- Payer and healthcare provider cost-containment measures.
- Ongoing patent litigations and exclusivity periods impacting biosimilar launches.
Price Sensitivity and Volume Impact
- Volume sales have increased as biosimilars gain market share.
- Substitution rates vary by region; U.S. substitution rates for biosimilars approximate 50-60%, influencing revenue expectations.
- Price reductions for biosimilars are partly offset by volume growth.
Investment and Business Implications
- Pfizer’s revenue from infliximab is under pressure due to biosimilar competition.
- Future profits depend on biosimilar market penetration, patent litigation outcomes, and potential new formulations.
- Launch of next-generation biosimilars or biosimilar combination therapies could disrupt current projections.
Key Takeaways
- NDC 63481-0628 (Remicade) maintains a substantial market presence but faces declining revenue margins due to biosimilar competition.
- The U.S. infliximab biosimilar market will likely reach 30-40% of total infliximab sales by 2025.
- Pricing for the originator will stabilize or grow modestly, while biosimilar prices will decline gradually.
- Patent protection extensions delay biosimilar market saturation, but this window is closing.
- Volume increases among biosimilars will impact overall market dynamics, counteracting some price reductions.
FAQs
1. When will biosimilar competition significantly impact NDC 63481-0628?
Market penetration accelerates once patent protections expire, expected around 2025-2026.
2. How will biosimilar price trends affect Pfizer’s revenue?
Biosimilar price reductions will decrease revenue per unit but potentially offset overall losses through volume growth.
3. What regions are most conducive to biosimilar adoption?
The U.S. and Europe lead in biosimilar adoption due to healthcare policies favoring cost-saving measures.
4. Are new formulations or indications likely to affect the market?
Yes. Additional indications or improved formulations could extend the product lifecycle and market dominance.
5. How does generic infliximab entry affect the overall market?
Biosimilars lower prices and increase accessibility but do not replace the patent-held originator entirely until exclusivity ends.
References
- IQVIA (2022). Biologic Market Reports.
- FDA (2022). Biosimilar Approvals.
- EvaluatePharma (2022). Global Cancer & Autoimmune Treatments Market Report.
- Sagonowsky, E. (2022). Biosimilar Market Trends. FiercePharma.
- Reuters (2022). Pfizer bottleneck with infliximab patent.
