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Biosimilar Infliximab
Biosimilar infliximab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.
Biosimilar infliximab 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 | Biosimilar Infliximab |
|---|---|
| Also known as | Remsima®, Inflectra, Remsima |
| Sponsor | Hikma Pharmaceuticals LLC |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology / Gastroenterology |
| Phase | FDA-approved |
Mechanism of action
Infliximab is a chimeric monoclonal antibody that binds with high affinity to soluble and membrane-bound TNF-α, preventing its interaction with TNF receptors on immune cells and endothelial cells. This blocks the inflammatory cascade driven by TNF-α, reducing production of other pro-inflammatory cytokines and adhesion molecules. As a biosimilar, it is bioequivalent to the reference infliximab product (Remicade) and has the same mechanism of action.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
- Behçet's disease
Common side effects
- Infections (including serious infections)
- Infusion reactions
- Headache
- Nausea
- Tuberculosis reactivation
- Opportunistic infections
- Injection site reactions
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:
- Biosimilar Infliximab CI brief — competitive landscape report
- Biosimilar Infliximab updates RSS · CI watch RSS
- Hikma Pharmaceuticals LLC portfolio CI