BLAINTRAVENOUSVIALPriority Review
Approved
Aug 1998
Lifecycle
LOE Approaching
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
Priority Review
REMICADE (infliximab) by Samsung Bioepis is tumor necrosis factor receptor blocking activity [moa]. First approved in 1998.
Drug data last refreshed 10m ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
REMICADE (infliximab) is a TNF-alpha receptor blocking monoclonal antibody administered intravenously to treat autoimmune and inflammatory conditions. It works by inhibiting tumor necrosis factor (TNF), a key inflammatory cytokine, thereby reducing inflammation across multiple disease states. The product is now marketed by Samsung Bioepis and has been a foundational biologic therapy since its 1998 FDA approval.
$0.111BPart D
LOE ApproachingDeclining
Product is in late-stage lifecycle with modest Part D spend; the brand team is likely focused on market defense and transition planning rather than expansion.
Mechanism of Action
Tumor Necrosis Factor Receptor Blocking Activity
Pharmacologic Class:
Tumor Necrosis Factor Blocker
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (20)
Zymfentra (Infliximab-dyyb) REal World Cohort STudy
Started Nov 2025
200 enrolled
Ulcerative Colitis (UC)Crohn's Disease (CD)Indeterminate Colitis+1 more
PROactive and Early Infliximab Monitoring and OPTimization in Inflammatory Bowel Disease
Started Jan 2025
72 enrolled
Inflammatory Bowel Disease (IBD)Crohn Disease (CD)Ulcerative Colitis (UC)
Subcutaneous Infliximab After A Previous Intravenous Dose Optimization
Started Apr 2024
275 enrolled
Inflammatory Bowel DiseasesCrohn DiseaseUlcerative Colitis
A Study to Learn About the Study Medicine Called Infliximab (Genetical Recombination)[Infliximab Biosimilar 3] in People With Rheumatoid Arthritis, Ulcerative Colitis, Crohn's Disease, or Psoriasis
Started Dec 2023
2,207 enrolled
Arthritis, RheumatoidColitis, UlcerativeCrohn Disease+1 more
Precise Infliximab Exposure and Pharmacodynamic Control
Started Jul 2023
180 enrolled
Crohn Disease
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.