EMA · European Union
adalimumab — EMA regulatory status
adalimumab (ABRILADA) regulatory status in the European Union is tracked from public EMA records and cross-linked clinical and patent datasets on NovaPharmaNews. Current status: EMA approved.
Status snapshot
- Status
- EMA approved
- Brand
- ABRILADA
- Originator
- Pfizer Australia Pty Ltd
- Mechanism
- TNF-alpha inhibitor
- Target
- Tumor necrosis factor
- Structured fields
- 8
Sponsor / originator context: Pfizer Australia Pty Ltd. Pipeline programs and exclusivity signals below are joined from ClinicalTrials.gov-linked projects and USPTO/EPO patent rows associated with this INN.
Pharmacology context used for competitive intelligence: TNF-alpha inhibitor. Target: Tumor necrosis factor. This page is a status aggregation for professional reference — not prescribing advice.
Regional decision snapshot — EMA: approved.
Linked evidence on this spoke: 57 published clinical programs and 12 related patent records. Use the tables below for NCT identifiers, phases, and exclusivity dates; verify against primary sources before BD or medical decisions.
Regulatory timeline
| Regulator | Region | Status | Date | Source |
|---|---|---|---|---|
| EMA | European Union | approved | — | Evidence |
Linked clinical programs
| Program | Phase | Sponsor | NCT |
|---|---|---|---|
| 20210184 | Phase 3 | Amgen | 2024-515523-11-00 |
| 20220196 | Phase 3 | Amgen | 2024-516652-18-00 |
| 20230225 | Phase 3 | Amgen | 2025-522703-14-00 |
| 207503 | Phase 3 | GSK Glaxo Smith | 2023-510537-28-00 |
| AMG 133, Placebo for Maridebart Cafraglutide | Phase 3 | Amgen | 2024-515524-36-00 |
| AMG 479 | Phase 3 | Takeda | NCT01231347 |
| AMG 706 | Phase 3 | Takeda | NCT00460317 |
| Adalimumab | Phase 3 | AbbVie | NCT03104400 |
| Adalimumab | Phase 3 | AbbVie | NCT06100744 |
| I4V-MC-JAHW | Phase 3 | Eli Lilly and | 2023-505811-18-00 |
| IM101-863 | Phase 3 | Bristol-Myers Squibb Australia | 2023-506450-20-00 |
| M10-870 | Phase 3 | AbbVie Deutschland GmbH | 2023-504711-32-00 |
Related patents
| Number | Title | Jurisdiction |
|---|---|---|
| 2026112486 | MÉTHODES DE TRAITEMENT DE L'OBÉSITÉ ET DES AFFECTIONS LIÉES À L'OBÉSITÉ | WO |
| 2026102199 | THÉRAPIE COMBINÉE D'UN INHIBITEUR DE PRMT5 ET DU DARAXONRASIB POUR UTILISATION DANS LE TRAITEMENT DU CANCER MTAP-NUL | WO |
| 2026072909 | PROTÉINES DE LIAISON À FLT1 ET MÉTHODES D'UTILISATION | WO |
| 2026055477 | COMPOSÉS MACROCYCLIQUES CONSTITUANT DES MODULATEURS DE KRAS ET LEURS UTILISATIONS | WO |
| 2026039538 | MÉTHODES DE TRAITEMENT DE TUMEURS PANCRÉATIQUES EXPRIMANT CERTAINS BIOMARQUEURS | WO |
| 2026039321 | MÉTHODES DE TRAITEMENT DU CANCER DE LA PROSTATE | WO |
| 2026020076 | MÉTHODE DE TRAITEMENT DU PRURIGO NODULAIRE | WO |
| 2026006398 | RÉDUCTASES D'IMINE MODIFIÉES ET LEURS PROCÉDÉS D'UTILISATION | WO |
| 2026006805 | COMPOSÉS À NOYAU À 6 CHAÎNONS UTILISÉS COMME MODULATEURS DE L'HÉLICASE À ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS | WO |
| 2026006803 | COMPOSÉS À NOYAU À 5 CHAÎNONS UTILISÉS EN TANT QUE MODULATEURS DE L'HÉLICASE D'ADN RECQ DU SYNDROME DE WERNER ET LEURS UTILISATIONS | WO |
| 2025265110 | COMPOSITIONS PHARMACEUTIQUES ORALES RENFERMANT UN COMPOSÉ DE NAPHTYRIDINE | WO |
| 2025259749 | FRAGMENTS VARIABLES À CHAÎNE UNIQUE STABLES | WO |
Related hubs
FAQ
What is the EMA approval status of adalimumab?
adalimumab currently shows EMA approved in our European Union regulatory index. Confirm on the official EMA label or EPAR before clinical or commercial use.
Where does NovaPharmaNews get adalimumab regulatory data?
Status fields are joined from public sources (openFDA / EMA / regional agencies), ClinicalTrials.gov-linked programs, and patent registries. See /about/data-sources for attribution.
How many clinical programs are linked to adalimumab?
This spoke lists 57 published programs associated with adalimumab in our pipeline index.