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US-licensed Humira
US-licensed Humira is a TNF-alpha inhibitor Biologic drug developed by Celltrion. It is currently in Phase 3 development for Rheumatoid Arthritis, Psoriatic Arthritis, Plaque Psoriasis. Also known as: Adalimumab.
Humira is a monoclonal antibody that targets and binds to tumor necrosis factor-alpha (TNF-alpha), preventing it from interacting with its cell surface receptor and thereby reducing inflammation.
US-licensed Humira is a medication that inhibits Interleukin-6, a protein involved in inflammation. It is used to treat conditions such as rheumatoid arthritis, as indicated by clinical trials registered on ClinicalTrials.gov.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Immunology slight uplift
+1.0pp
Mature endpoint landscape (ACR, DAS28, PASI) makes immunology approvals slightly more predictable.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | US-licensed Humira |
|---|---|
| Also known as | Adalimumab |
| Sponsor | Celltrion |
| Drug class | TNF-alpha inhibitor |
| Target | TNF-alpha |
| Modality | Biologic |
| Therapeutic area | Immunology |
| Phase | Phase 3 |
Mechanism of action
By binding to TNF-alpha, Humira inhibits the inflammatory cascade, which is a key component of various autoimmune diseases. This results in reduced inflammation and alleviation of symptoms associated with conditions such as rheumatoid arthritis and psoriasis.
Approved indications
- Rheumatoid Arthritis
- Psoriatic Arthritis
- Plaque Psoriasis
- Crohn's Disease
- Ulcerative Colitis
- Juvenile Idiopathic Arthritis
- Ankylosing Spondylitis
Common side effects
- Injection site reactions
- Headache
- Fatigue
- Musculoskeletal pain
- Nausea
- Diarrhea
- Abdominal pain
Key clinical trials
- To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects (PHASE1)
- Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab) (PHASE1)
- To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects (PHASE1)
- MSB11022 in Healthy Subjects (PHASE1)
- Clinical Trial to Compare Treatment With GP2017 and Humira® in Patients With Rheumatoid Arthritis (PHASE3)
- BI 695501 Compared to Adalimumab in Patients With Active Rheumatoid Arthritis (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:
- US-licensed Humira CI brief — competitive landscape report
- US-licensed Humira updates RSS · CI watch RSS
- Celltrion portfolio CI
Frequently asked questions about US-licensed Humira
What is US-licensed Humira?
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Is US-licensed Humira also known as anything else?
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What does US-licensed Humira target?
Related
- Drug class: All TNF-alpha inhibitor drugs
- Target: All drugs targeting TNF-alpha
- Manufacturer: Celltrion — full pipeline
- Therapeutic area: All drugs in Immunology
- Indication: Drugs for Rheumatoid Arthritis
- Indication: Drugs for Psoriatic Arthritis
- Indication: Drugs for Plaque Psoriasis
- Also known as: Adalimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing