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SB5 (Adalimumab Biosimilar)
SB5 (Adalimumab Biosimilar) is a TNF-α inhibitor (monoclonal antibody biosimilar) Small molecule drug developed by Samsung Bioepis Co., Ltd.. It is currently FDA-approved for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.
SB5 is a biosimilar of adalimumab that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling.
SB5 is a biosimilar of adalimumab that binds to and neutralizes tumor necrosis factor-alpha (TNF-α), reducing inflammatory signaling. Used for Rheumatoid arthritis, Ankylosing spondylitis, Psoriatic arthritis.
At a glance
| Generic name | SB5 (Adalimumab Biosimilar) |
|---|---|
| Sponsor | Samsung Bioepis Co., Ltd. |
| Drug class | TNF-α inhibitor (monoclonal antibody biosimilar) |
| Target | TNF-α (tumor necrosis factor-alpha) |
| Modality | Small molecule |
| Therapeutic area | Immunology |
| Phase | FDA-approved |
Mechanism of action
SB5 is a monoclonal antibody biosimilar that mimics the mechanism of reference adalimumab by binding to soluble and membrane-bound TNF-α, preventing its interaction with TNF receptors on immune cells. This blocks TNF-α-mediated inflammation and is used to treat TNF-driven autoimmune and inflammatory diseases. As a biosimilar, SB5 demonstrates comparable efficacy and safety to the reference product while offering potential cost advantages.
Approved indications
- Rheumatoid arthritis
- Ankylosing spondylitis
- Psoriatic arthritis
- Crohn's disease
- Ulcerative colitis
- Psoriasis
- Hidradenitis suppurativa
Common side effects
- Injection site reactions
- Upper respiratory tract infections
- Headache
- Serious infections
- Tuberculosis reactivation
Key clinical trials
- Pharmacokinetics, Efficacy, Safety, and Immunogenicity of SB5 Versus Humira in Subjects With Moderate to Severe Chronic Plaque Psoriasis (PHASE4)
- A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy (PHASE3)
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:
- SB5 (Adalimumab Biosimilar) CI brief — competitive landscape report
- SB5 (Adalimumab Biosimilar) updates RSS · CI watch RSS
- Samsung Bioepis Co., Ltd. portfolio CI
Frequently asked questions about SB5 (Adalimumab Biosimilar)
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Related
- Drug class: All TNF-α inhibitor (monoclonal antibody biosimilar) drugs
- Target: All drugs targeting TNF-α (tumor necrosis factor-alpha)
- Manufacturer: Samsung Bioepis Co., Ltd. — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid arthritis
- Indication: Drugs for Ankylosing spondylitis
- Indication: Drugs for Psoriatic arthritis
- Compare: SB5 (Adalimumab Biosimilar) vs similar drugs
- Pricing: SB5 (Adalimumab Biosimilar) cost, discount & access