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Adalimumab - US licensed 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, Crohn's disease, Ulcerative colitis.
At a glance
| Generic name | Adalimumab - US licensed Humira |
|---|---|
| Also known as | Humira - Comparator |
| Sponsor | Sandoz |
| Drug class | TNF-α inhibitor (monoclonal antibody) |
| Target | TNF-α (Tumor Necrosis Factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By blocking TNF-α, adalimumab reduces inflammation and suppresses the immune response in autoimmune and inflammatory conditions. This TNF inhibition decreases the production of other inflammatory mediators and reduces immune cell activation, providing therapeutic benefit in conditions driven by excessive TNF-α signaling.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Juvenile idiopathic arthritis
- Polyarticular juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections (including tuberculosis)
- Malignancy risk
Key clinical trials
- To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects (PHASE1)
- 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)
- Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (PHASE3)
- BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis (PHASE3)
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:
- Adalimumab - US licensed Humira CI brief — competitive landscape report
- Adalimumab - US licensed Humira updates RSS · CI watch RSS
- Sandoz portfolio CI