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ABP 501
ABP 501 is a biosimilar of adalimumab that blocks tumor necrosis factor-alpha (TNF-α) to reduce inflammation.
ABP 501 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 | ABP 501 |
|---|---|
| Also known as | AMJEVITA™, Adalimumab-atto |
| Sponsor | Amgen |
| Drug class | TNF-α inhibitor (biosimilar) |
| Target | TNF-α |
| Modality | Biologic |
| Therapeutic area | Immunology / Rheumatology |
| Phase | Phase 3 |
Mechanism of action
ABP 501 is a monoclonal antibody that binds to and neutralizes TNF-α, a key inflammatory cytokine. By inhibiting TNF-α signaling, it suppresses the inflammatory cascade involved in autoimmune and inflammatory diseases. This mechanism is identical to the reference biologic adalimumab (Humira).
Approved indications
- Rheumatoid arthritis
- Crohn's disease
- Ulcerative colitis
- Ankylosing spondylitis
- Psoriatic arthritis
- Psoriasis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections
- Tuberculosis reactivation
Key clinical trials
- Lenalidomide, Ibrutinib, and Rituximab in Treating Patients With Relapsed or Refractory Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma That Is Metastatic or Cannot Be Removed by Surgery (PHASE1)
- Efficacy of Different Biological Treatments in Patients With Inflammatory Bowel Disease After One Year of Treatment in Upper Egypt
- Rituximab and Combination Chemotherapy With or Without Lenalidomide in Treating Patients With Newly Diagnosed Stage II-IV Diffuse Large B Cell Lymphoma (PHASE2)
- Subconjunctival Humira for Boston Keratoprosthesis (PHASE1)
- Rituximab, Lenalidomide, and Ibrutinib in Treating Patients With Previously Untreated Stage II-IV Follicular Lymphoma (PHASE1)
- Testing the Addition of Lenalidomide and Nivolumab to the Usual Treatment for Primary CNS Lymphoma (PHASE1)
- Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission (NA)
- Intravitreal Adalimumab in Inherited and Degenerative Retinal Diseases (PHASE1, 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:
- ABP 501 CI brief — competitive landscape report
- ABP 501 updates RSS · CI watch RSS
- Amgen portfolio CI