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EU-approved Humira
EU-approved Humira is a TNF-alpha inhibitor Biologic drug developed by Celltrion. It is currently in Phase 3 development for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.
Humira is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha, a key inflammatory cytokine driving autoimmune and inflammatory diseases.
Humira is a TNF-alpha inhibitor that blocks tumor necrosis factor-alpha, a key inflammatory cytokine driving autoimmune and inflammatory diseases. Used for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.
At a glance
| Generic name | EU-approved Humira |
|---|---|
| Sponsor | Celltrion |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha (Tumor Necrosis Factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
Humira (adalimumab) binds directly to soluble and membrane-bound TNF-alpha, preventing its interaction with TNF receptors on immune cells and reducing the inflammatory cascade. This suppresses the production of pro-inflammatory cytokines and chemokines, thereby reducing inflammation and immune-mediated tissue damage across multiple organ systems.
Approved indications
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Hidradenitis suppurativa
- Juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections (including tuberculosis)
- Malignancy risk
- Demyelinating disease
Key clinical trials
- To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab) (PHASE1)
- To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects (PHASE1)
- MSB11022 in Healthy Subjects (PHASE1)
- Comparative Safety, Tolerability, Pharmacokinetic Study of AVT02 (100MG/ML) and Humira (100MG/ML) in Healthy Volunteers (PHASE1)
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:
- EU-approved Humira CI brief — competitive landscape report
- EU-approved Humira updates RSS · CI watch RSS
- Celltrion portfolio CI
Frequently asked questions about EU-approved Humira
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Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha (Tumor Necrosis Factor-alpha)
- Manufacturer: Celltrion — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Ankylosing spondylitis
- Indication: Drugs for Psoriatic arthritis
- Compare: EU-approved Humira vs similar drugs
- Pricing: EU-approved Humira cost, discount & access