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EU-licensed Humira
EU-licensed Humira is a Small molecule drug developed by Prestige Biopharma Limited. It is currently in Phase 1 development. Also known as: Adalimumab.
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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 | EU-licensed Humira |
|---|---|
| Also known as | Adalimumab |
| Sponsor | Prestige Biopharma Limited |
| Modality | Small molecule |
| Phase | Phase 1 |
Approved indications
Common side effects
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)
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-licensed Humira CI brief — competitive landscape report
- EU-licensed Humira updates RSS · CI watch RSS
- Prestige Biopharma Limited portfolio CI
Frequently asked questions about EU-licensed Humira
What is EU-licensed Humira?
Who makes EU-licensed Humira?
Is EU-licensed Humira also known as anything else?
What development phase is EU-licensed Humira in?
Related
- Manufacturer: Prestige Biopharma Limited — full pipeline
- Also known as: Adalimumab
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing