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CT-P13
CT-P13 is a biosimilar of infliximab that binds to tumor necrosis factor-alpha (TNF-α) to reduce inflammatory signaling.
CT-P13 is a biosimilar of infliximab that binds to tumor necrosis factor-alpha (TNF-α) to reduce inflammatory signaling. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.
At a glance
| Generic name | CT-P13 |
|---|---|
| Also known as | Infliximab, Inflectra, Remsima |
| Sponsor | CMC Ambroise Paré |
| Drug class | TNF-α inhibitor (biosimilar) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Small molecule |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
CT-P13 is a monoclonal antibody that targets and neutralizes TNF-α, a key pro-inflammatory cytokine. By blocking TNF-α, it suppresses the inflammatory cascade involved in autoimmune and inflammatory diseases. This mechanism is identical to the reference biologic infliximab, making CT-P13 a biosimilar with comparable efficacy and safety.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
Common side effects
- Infections (including serious infections)
- Infusion reactions
- Headache
- Nausea
- Tuberculosis reactivation
Key clinical trials
- Role of Gut Microbiome and Fecal Transplant on Medication-Induced GI Complications in Patients With Cancer (PHASE1)
- Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease (NA)
- Infliximab or Vedolizumab in Treating Immune Checkpoint Inhibitor-Related Colitis in Patients With Genitourinary Cancer or Melanoma (PHASE1, PHASE2)
- MIS-C Comparative Effectiveness Study (PHASE2, PHASE3)
- A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
- A Phase 3 Study to Evaluate Efficacy & Safety of Subcutaneous CT-P13 in Patients With Moderate to Severe Active Rheumatoid Arthritis (PHASE3)
- Anti-tumor Necrosis Factor in Patients With Ulcerative Colitis in Clinical Remission: to Continue or Not? (NA)
- Post-Operative Crohn's Disease Outcome in Children
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:
- CT-P13 CI brief — competitive landscape report
- CT-P13 updates RSS · CI watch RSS
- CMC Ambroise Paré portfolio CI