BLAINJECTIONINJECTABLE
Approved
Apr 2017
Lifecycle
Peak
Competitive Pressure
30/100
Clinical Trials
20
Data completeness
4/8 — Partial
RENFLEXIS (infliximab) by Samsung Bioepis is tumor necrosis factor receptor blocking activity [moa]. First approved in 2017.
Drug data last refreshed 9h ago · AI intelligence enriched 1mo ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
RENFLEXIS is a biosimilar infliximab (TNF-alpha inhibitor) approved in 2017 for autoimmune inflammatory conditions including rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriasis, and psoriatic arthritis. It works by blocking tumor necrosis factor (TNF), a key inflammatory cytokine driving disease pathogenesis. As a monoclonal antibody biosimilar, it offers a cost-effective alternative to the reference product.
$0.263BPart D
PeakRENFLEXIS is in peak commercial phase with stable Medicare Part D utilization; teams are likely focused on market maintenance and defending share against biosimilar competition rather than growth 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)
Infliximab for Cytokine Release Syndrome Prophylaxis During Teclistamab or Talquetamab Therapy in Patients With Relapsed or Refractory Myeloma
Started Jul 2026
35 enrolled
Cytokine Release SyndromeRecurrent Multiple MyelomaRefractory Multiple Myeloma
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
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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.