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EU-Humira
EU-Humira is a Small molecule drug developed by Fresenius Kabi SwissBioSim GmbH. It is currently in Phase 3 development. Also known as: Adalimumab.
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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).
| 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 | EU-Humira |
|---|---|
| Also known as | Adalimumab |
| Sponsor | Fresenius Kabi SwissBioSim GmbH |
| Modality | Small molecule |
| Phase | Phase 3 |
Approved indications
Common side effects
- Nasopharyngitis
- Injection site erythema
- Injection site pain
- Erythema
- Injection site pruritus
Key clinical trials
- To Compare the Pharmacokinetics and Safety of PBP1502 and Humira in Healthy Subjects (PHASE1)
- To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- MSB11022 in Moderate to Severe Chronic Plaque Psoriasis (PHASE3)
- A Real-world Study of Imraldi® Use
- 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)
- The Purpose of This Research Study is to Compare the Efficacy and Safety of SCT630 and Adalimumab (HUMIRA®) in Adults With Plaque Psoriasis (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:
- EU-Humira CI brief — competitive landscape report
- EU-Humira updates RSS · CI watch RSS
- Fresenius Kabi SwissBioSim GmbH portfolio CI
Frequently asked questions about EU-Humira
What is EU-Humira?
Who makes EU-Humira?
Is EU-Humira also known as anything else?
What development phase is EU-Humira in?
What are the side effects of EU-Humira?
Related
- Manufacturer: Fresenius Kabi SwissBioSim GmbH — full pipeline
- Also known as: Adalimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing