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SB5
SB5 is a monoclonal antibody that binds to and inhibits tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.
SB5 is a monoclonal antibody that binds to and inhibits tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling. Used for Rheumatoid arthritis, Psoriasis, Psoriatic arthritis.
At a glance
| Generic name | SB5 |
|---|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
| Drug class | TNF-α inhibitor (monoclonal antibody); biosimilar |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Biologic |
| Therapeutic area | Immunology; Rheumatology |
| Phase | FDA-approved |
Mechanism of action
SB5 is a biosimilar of adalimumab, a TNF-α inhibitor used to treat inflammatory and autoimmune diseases. By neutralizing TNF-α, a key pro-inflammatory cytokine, SB5 suppresses the immune response and reduces inflammation in conditions such as rheumatoid arthritis, psoriasis, and inflammatory bowel disease.
Approved indications
- Rheumatoid arthritis
- Psoriasis
- Psoriatic arthritis
- Ankylosing spondylitis
- Crohn's disease
- Ulcerative colitis
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections
- Tuberculosis reactivation
Key clinical trials
- Combination, Miltefosine Monotherapy for Cutaneous Leishmaniasis in New World (PHASE3)
- Early, Objective Detection of Autism. (NA)
- Treatment of Mucosal Bolivian Leishmaniasis (PHASE3)
- Congenital Heart Disease: Impact on Learning and Development in Down Syndrome (CHILD-DS)
- Topical Sm29 in Combination With Meglumine Antimoniate in the Treatment of Cutaneous Leishmaniasis. (PHASE1, PHASE2)
- Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis (PHASE4)
- Pharmacokinetics, Safety, Tolerability, and Immunogenicity of Two Formulations of SB5 in Healthy Male Subjects (PHASE1)
- Intralesional Antimony for Bolivian Cutaneous Leishmaniasis (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 |