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US-Humira
US-Humira is a Biologic drug developed by Mylan Inc.. It is currently in Phase 1 development. Also known as: Adalimumab.
US-Humira is a US-licensed version of the drug Humira, which is an interleukin-6 inhibitor used to treat conditions such as rheumatoid arthritis. It belongs to the drug class of inhibitors.
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Baseline phase 1 → approval rate
+9.6pp
Industry-wide phase 1 drugs reach approval ~9.6% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2033–2036 | — |
| EMA | EU | 2034–2037 | +0.7 yr |
| MHRA | GB | 2034–2037 | +0.7 yr |
| Health Canada | CA | 2034–2038 | +0.9 yr |
| TGA | AU | 2034–2038 | +1.2 yr |
| PMDA | JP | 2034–2038 | +1.5 yr |
| NMPA | CN | 2035–2039 | +2.3 yr |
| MFDS | KR | 2034–2038 | +1.4 yr |
| CDSCO | IN | 2034–2039 | +1.8 yr |
| ANVISA | BR | 2035–2039 | +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-Humira |
|---|---|
| Also known as | Adalimumab |
| Sponsor | Mylan Inc. |
| Modality | Biologic |
| Phase | Phase 1 |
Approved indications
Common side effects
Key clinical trials
- A Study to Assess the Long-Term Safety of Ustekinumab Versus Other Biologics in Patients With Crohn's Disease and Ulcerative Colitis
- To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects (PHASE1)
- A Study of Comparing Rates of Dementia and Alzheimer's Disease in Participants Initiating Methotrexate Versus Those Initiating Anti-tumor Necrosis Factor (TNF)-Alpha Therapy
- A Comparative Study Between ABP 501 and Humira® in Participants With Moderate to Severe Plaque Psoriasis (PHASE3)
- Pharmacokinetics, Safety and Tolerability Study of AVT02 to EU-approved and US-licensed Humira (Adalimumab) (PHASE1)
- Adalimumab PK Bioequivalence Study to EU and US Sourced Humira (PHASE1)
- To Compare the Pharmacokinetics and Safety of CT-P17 and Humira in Healthy Subjects (PHASE1)
- Safety Study Of Tofacitinib Versus Tumor Necrosis Factor (TNF) Inhibitor In Subjects With Rheumatoid Arthritis (PHASE4)
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-Humira CI brief — competitive landscape report
- US-Humira updates RSS · CI watch RSS
- Mylan Inc. portfolio CI
Frequently asked questions about US-Humira
What is US-Humira?
Who makes US-Humira?
Is US-Humira also known as anything else?
What development phase is US-Humira in?
Related
- Manufacturer: Mylan Inc. — full pipeline
- Also known as: Adalimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing