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Infliximab subcutaneous
Infliximab subcutaneous is a TNF-α inhibitor (monoclonal antibody) Small molecule drug developed by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA). It is currently in Phase 3 development for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis. Also known as: Remsima 120mg solution s.c..
Infliximab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.
Infliximab is a subcutaneous medication used to treat conditions such as Relapsing Polychondritis, Inflammatory Bowel Disease, Ulcerative Colitis, Crohn's Disease, and Inflammatory Bowel Diseases. It works as a TNF-alpha inhibitor, belonging to the class of INHIBITOR drugs, which are antibody-based medications that target tumor necrosis factor.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Infliximab subcutaneous |
|---|---|
| Also known as | Remsima 120mg solution s.c. |
| Sponsor | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking TNF-α, infliximab reduces inflammatory signaling and immune activation in conditions driven by excessive TNF production. The subcutaneous formulation allows for patient self-administration and may improve convenience compared to intravenous dosing. This mechanism is effective in autoimmune and inflammatory diseases where TNF-α plays a central pathogenic role.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Plaque psoriasis
Common side effects
- Infections (including serious infections)
- Injection site reactions
- Headache
- Upper respiratory tract infections
- Tuberculosis reactivation
- Malignancy risk
Key clinical trials
- A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (PHASE3)
- An Open-Label Study of Effectiveness of Immunomodulatory Medications for Patients With Relapsing Polychondritis (PHASE2)
- Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial (NA)
- Switching From Intravenous to Subcutaneous Infliximab in Adult Patients With Inflammatory Bowel Disease (NA)
- Sub-cutaneous Infliximab in Inflammatory Rheumatic Disease
- A Pharmacokinetic-pharmacodynamic Modeling and Simulation Study of Subcutaneous Infliximab in Patients With Inflammatory Bowel Disease
- Immunosuppressant Management in Rheumatology Patients Undergoing Elective Total Shoulder Arthroplasty (PHASE2)
- EFFICACI : EFFicacy of Intravenous Infliximab Versus Vedolizumab After Failure of subCutaneous Anti-TNF in Patients With UlCerative Colitis (PHASE4)
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 subcutaneous CI brief — competitive landscape report
- Infliximab subcutaneous updates RSS · CI watch RSS
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) portfolio CI
Frequently asked questions about Infliximab subcutaneous
What is Infliximab subcutaneous?
How does Infliximab subcutaneous work?
What is Infliximab subcutaneous used for?
Who makes Infliximab subcutaneous?
Is Infliximab subcutaneous also known as anything else?
What drug class is Infliximab subcutaneous in?
What development phase is Infliximab subcutaneous in?
What are the side effects of Infliximab subcutaneous?
What does Infliximab subcutaneous target?
Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Crohn's disease
- Indication: Drugs for Ulcerative colitis
- Also known as: Remsima 120mg solution s.c.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing