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Infliximab biosimilar
Infliximab biosimilar is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.
Infliximab biosimilar is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.
At a glance
| Generic name | Infliximab biosimilar |
|---|---|
| Also known as | Remsima, Remsima® or Inflectra®, Flixabi® |
| Sponsor | Hanyang University Seoul Hospital |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
TNF-α is a key pro-inflammatory cytokine that drives inflammation in autoimmune and inflammatory diseases. By binding to TNF-α, infliximab prevents its interaction with TNF receptors on immune cells and endothelial cells, thereby suppressing the inflammatory cascade. This biosimilar is therapeutically equivalent to the reference infliximab product.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Tuberculosis (adjunctive)
Common side effects
- Infections (including serious infections)
- Infusion reactions
- Headache
- Nausea
- Tuberculosis reactivation
- Opportunistic infections
Key clinical trials
- Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital
- Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Rheumatoid Arthritis)
- Multicenter Randomized Double Blind Controlled-study to Assess the Potential of Methotrexate Versus Placebo to Improve and Maintain Response to Anti TNF- Alpha Agents in Adult Patients With Moderate to Severe Psoriasis (PHASE4)
- Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
- Infliximab Biosimilar for Intravenous Drip Infusion 100 mg "Pfizer" Drug Use Investigation (Psoriasis)
- Biologics in Refractory Vasculitis: A Trial of Biologic Therapy for Refractory Primary Non-ANCA Associated Vasculitis (PHASE2)
- 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
- Infliximab Biosimilar "Pfizer" Drug Use Investigation (Crohn's Disease or Ulcerative Colitis)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Infliximab biosimilar CI brief — competitive landscape report
- Infliximab biosimilar updates RSS · CI watch RSS
- Hanyang University Seoul Hospital portfolio CI