Last reviewed · How we verify
Adalimumab and its biosimilars
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 and its biosimilars |
|---|---|
| Also known as | Humira, Adaloce |
| Sponsor | Hanyang University Seoul Hospital |
| 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 clinical improvement in autoimmune and inflammatory diseases. Biosimilars are biologically equivalent versions manufactured by different companies with comparable efficacy and safety profiles.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
- Hidradenitis suppurativa
- Juvenile idiopathic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Tuberculosis reactivation
- Serious infections
- Malignancy risk
Key clinical trials
- A Trial of Academic Detailing to Promote Prescribing of Biosimilars (NA)
- SKIN Disease Profiling by an Exploratory, pRospective, Biomarker Study in dermatoloGY Practice (SKINERGY)
- A Study of JNJ-64304500 as Add-on Therapy in Participants With Active Crohn's Disease (PHASE2)
- PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI) (PHASE1)
- Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab) (PHASE1)
- REduCed Dose of TNFi in Patients With Ankylosing SpondyliTis (RECAST) (PHASE4)
- A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar
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 and its biosimilars CI brief — competitive landscape report
- Adalimumab and its biosimilars updates RSS · CI watch RSS
- Hanyang University Seoul Hospital portfolio CI