Last reviewed · How we verify
AVT03
AVT03 is a biosimilar of adalimumab that blocks tumor necrosis factor-alpha (TNF-α) to reduce inflammation.
AVT03 is a biosimilar of adalimumab that blocks tumor necrosis factor-alpha (TNF-α) to reduce inflammation. Used for Rheumatoid arthritis, Crohn's disease, Ulcerative colitis.
At a glance
| Generic name | AVT03 |
|---|---|
| Also known as | AVT03, Biosimilar Denosumab, AVT03 proposed Biosimilar to Denosumab |
| Sponsor | Alvotech Swiss AG |
| Drug class | TNF-α inhibitor (monoclonal antibody biosimilar) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
AVT03 is a monoclonal antibody that binds to and neutralizes TNF-α, a key inflammatory cytokine. By inhibiting TNF-α signaling, it reduces inflammatory responses in autoimmune and inflammatory conditions. As a biosimilar, it is designed to have equivalent efficacy and safety to the reference biologic adalimumab.
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Ankylosing spondylitis
- Psoriatic arthritis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Increased infection risk
Key clinical trials
- Multicenter Study in Postmenopausal Women With Osteoporosis, ALVOBOND (PHASE3)
- AVT03 With Xgeva in Healthy Male Subjects (PHASE1)
- AVT03 With Prolia in Healthy Male Subjects (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 |