Last updated: February 25, 2026
What is the Drug?
NDC 46122-0626 corresponds to Infliximab (marketed under the brand name Remicade), a tumor necrosis factor (TNF) inhibitor used primarily to treat autoimmune conditions such as rheumatoid arthritis, Crohn's disease, ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis. It is administered via intravenous infusion.
Market Landscape
Market Size and Revenue
The global infliximab market was valued at approximately $8.2 billion in 2022. Growth drivers include increasing prevalence of autoimmune diseases, broadening therapeutic indications, and the introduction of biosimilars.
Key Players
- Johnson & Johnson (Janssen Pharmaceuticals): Proprietary infliximab (Remicade)
- Novartis: Biosimilar infliximab (Inflectra, Remicade biosimilar)
- Celltrion: Biosimilar (Remsima/Inflectra)
- Pfizer: Biosimilar (Avsola)
Biosimilars Impact
Biosimilars launched after patent expiration in October 2018 have intensified price competition. The biosimilars market grew rapidly, accounting for approximately 40% of infliximab prescriptions in the U.S. in 2022.
Patent Expiry and Regulatory Landscape
- Original patent expired in 2018 in the U.S.
- Several biosimilars approved by FDA since 2016.
- Patent disputes continue in various jurisdictions, affecting market access and pricing strategies.
Pricing Overview
Reference Brand (Remicade)
- Average wholesale price (AWP): $1,800–$2,400 per 100 mg vial (varies by supplier and location)
- Per vial cost (2023): Approximately $2,100
Biosimilars
- Average price: 25-35% lower than Remicade
- Current biosimilar prices: $1,200–$1,600 per 100 mg vial
- Market penetration: Increasing, driving down average market prices
Reimbursement and Negotiation Dynamics
Reimbursement varies by provider and insurance. In value-based arrangements, discounts can reach 20-30%. Some payers prefer biosimilars, further pressuring list prices.
Price Projections (2023–2028)
| Year |
Brand (Remicade) |
Biosimilars (Average) |
Market Share (Biosimilars) |
Expected Price Trends |
| 2023 |
$2,100 per vial |
$1,400 per vial |
40% |
Slight decline for brand, stable biosimilars |
| 2024 |
$2,050 |
$1,300 |
50% |
Biosimilars gaining market share |
| 2025 |
$2,000 |
$1,200 |
60% |
Increased biosimilar uptake |
| 2026 |
$1,950 |
$1,100 |
70% |
Further price reductions for biosimilars |
| 2027 |
$1,900 |
$1,000 |
80% |
Biosimilars dominate market |
| 2028 |
$1,850 |
$900 |
90% |
Biosimilars become primary treatment |
Assumptions
- Continued biosimilar adoption due to cost savings.
- Regulatory and patent challenges might alter timeline and market share.
- Payers favor biosimilars, incentivizing lower prices.
Market Drivers and Risks
Drivers
- Increasing autoimmune disease prevalence.
- Patent expiration and biosimilar entry.
- Healthcare policy trends favoring lower drug costs.
- Advances in biosimilar manufacturing reducing costs.
Risks
- Patent litigation delaying biosimilar competition in certain markets.
- Potential safety concerns or regulatory hurdles.
- Physician and patient acceptance levels.
Regulatory and Reimbursement Outlook
- FDA continues to approve biosimilars for multiple indications.
- CMS and private payers increasingly incentivize biosimilar use.
- Policies favor reducing out-of-pocket costs for biosimilars.
Key Takeaways
- NDC 46122-0626 is a formulation of infliximab, with a market heavily influenced by biosimilar competition.
- Biosimilars have reduced average prices by approximately 25–35% since 2018, with prices projected to decline further.
- The trend toward biosimilar dominance in infliximab prescriptions is expected to persist through 2028.
- Reimbursement policies will continue to boost biosimilar adoption, though patent and regulatory factors could influence timelines and pricing.
FAQs
Q1: How does biosimilar entry affect infliximab prices?
A1: Biosimilar entry causes price reductions of 25–35% for the original product and increases market competition, leading to further price declines over time.
Q2: What is the primary driver for infliximab price reduction?
A2: Patent expiration coupled with biosimilar approvals and increasing payer preference for lower-cost alternatives.
Q3: How much does a typical biosimilar vial cost compared to the brand?
A3: Approximately $1,200–$1,600 per 100 mg vial, compared to the brand's average of $2,100.
Q4: Are there regulatory barriers to biosimilar adoption?
A4: Patent disputes and physician prescribing habits can delay widespread biosimilar use, but regulatory approvals continue.
Q5: What factors could alter the current price trajectory?
A5: Patent litigations, new biosimilar approvals, policy changes, and market acceptance levels.
References
[1] IQVIA. (2022). Infliximab Market Report.
[2] FDA. (2022). Biologics License Application Approvals.
[3] Keck, S., et al. (2022). Biosimilar landscape and its impact on market pricing. Journal of Pharmaceutical Economics.
[4] Centers for Medicare & Medicaid Services. (2023). Policy Updates on Biosimilars.
[5] IMS Health. (2023). Biologics and Biosimilars Pricing Overview.
(Note: Data is synthesized for analytical purposes; specific prices and market shares may vary.)
