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Humira® (Adalimumab)
Humira® (Adalimumab) is a TNF-α inhibitor (monoclonal antibody) Biologic drug developed by Mylan Inc.. It is currently FDA-approved for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis. Also known as: ABT-D2E7, adalimumab, Humira.
Adalimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine.
Adalimumab is a monoclonal antibody that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), a key inflammatory cytokine. Used for Rheumatoid arthritis, Psoriatic arthritis, Ankylosing spondylitis.
At a glance
| Generic name | Humira® (Adalimumab) |
|---|---|
| Also known as | ABT-D2E7, adalimumab, Humira |
| Sponsor | Mylan Inc. |
| 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
By blocking TNF-α, adalimumab reduces inflammatory signaling and immune activation in conditions driven by excessive TNF-α production. This leads to decreased inflammation, reduced immune cell infiltration, and suppression of disease progression in autoimmune and inflammatory disorders. TNF-α is a central mediator of inflammation in rheumatoid arthritis, psoriasis, inflammatory bowel disease, and other immune-mediated conditions.
Approved indications
- Rheumatoid arthritis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
- Plaque psoriasis
- Hidradenitis suppurativa
- Polyarticular juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Tuberculosis reactivation
- Serious infections
- Malignancy risk
Key clinical trials
- Treatment Tapering in JIA With Inactive Disease (PHASE3)
- Preventing Structural Damage in Early Psoriatic Arthritis (PHASE4)
- A Trial to Assess the Pharmacokinetic Similarity Between CHS-1420 40 mg/0.4 mL and HUMIRA® (Adalimumab) 40 mg/0.4 mL in Healthy Chinese Adult Participants Under Fasting Conditions (PHASE1)
- A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- A Study to Test the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis (PHASE3)
- Diabetes Islet Preservation Immune Treatment (PHASE1, PHASE2)
- Observational Study, to Assess Treatment Retention of an Adalimumab Biosimilar (Hyrimoz®) in IBD Patients in Real Life Setting
- 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)
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:
- Humira® (Adalimumab) CI brief — competitive landscape report
- Humira® (Adalimumab) updates RSS · CI watch RSS
- Mylan Inc. portfolio CI
Frequently asked questions about Humira® (Adalimumab)
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Related
- Drug class: All TNF-α inhibitor (monoclonal antibody) drugs
- Target: All drugs targeting TNF-α (Tumor Necrosis Factor-alpha)
- Manufacturer: Mylan Inc. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Psoriatic arthritis
- Indication: Drugs for Ankylosing spondylitis
- Also known as: ABT-D2E7, adalimumab, Humira
- Compare: Humira® (Adalimumab) vs similar drugs
- Pricing: Humira® (Adalimumab) cost, discount & access