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Adalimumab PFS and Pen
TNF-alpha inhibitor
TNF-alpha inhibitor Used for Rheumatoid Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis.
At a glance
| Generic name | Adalimumab PFS and Pen |
|---|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | Phase 2 |
Mechanism of action
Adalimumab is a fully human monoclonal antibody that selectively binds to tumor necrosis factor-alpha (TNF-alpha) and inhibits its interaction with cell surface TNF receptors. This action prevents TNF-alpha from inducing inflammation and cell death.
Approved indications
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Ankylosing Spondylitis
- Crohn's Disease
- Ulcerative Colitis
Common side effects
- Injection site reaction
- Headache
- Fatigue
- Nausea
- Diarrhea
Key clinical trials
- Experimental Medicine Studies of the Brain in Patients With Rheumatoid Arthritis REALISE (NA)
- PK, Safety and Tolerability Study of AVT02 (Adalimumab) Pre-filled Syringe (PFS) vs, AVT02 Autoinjector (AI) (PHASE1)
- An Multicentre Clinical Study to Evaluate the Usability and Safety of the Pre-filled Pen and Pre-filled Syringe of SB5 in Subjects With Rheumatoid Arthritis (PHASE2)
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 PFS and Pen CI brief — competitive landscape report
- Adalimumab PFS and Pen updates RSS · CI watch RSS
- Samsung Bioepis Co., Ltd. portfolio CI