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New formulation adalimumab
New formulation adalimumab is a Biologic drug developed by AbbVie (prior sponsor, Abbott). It is currently in Phase 2 development. Also known as: Humira.
Adalimumab is a medication used to treat rheumatoid arthritis, as indicated by ClinicalTrials.gov. A study (NCT01712178) compared the pharmacokinetic, pharmacodynamic, and safety profiles of the current and new formulations of adalimumab in patients with rheumatoid arthritis.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas). -
Big-pharma sponsor
+3.0pp
AbbVie (prior sponsor, Abbott) is a top-20 pharma sponsor — historical approval rates run ~3pp above average due to scale, regulatory experience, and trial-design quality.
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +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 | New formulation adalimumab |
|---|---|
| Also known as | Humira |
| Sponsor | AbbVie (prior sponsor, Abbott) |
| Modality | Biologic |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Study in Rheumatoid Arthritis for Subjects Who Completed Preceding Study M13-390 With Adalimumab (PHASE2)
- A Study in Rheumatoid Arthritis (RA) Patients to Compare Two Formulations of Adalimumab for Pharmacokinetic, Pharmacodynamic and Safety (PHASE2)
- A Crossover Study of the Safety and Tolerability of Two Formulations of Adalimumab (PHASE2)
- Crossover Study of Safety and Tolerability of Two Formulations of Adalimumab. (PHASE2)
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:
- New formulation adalimumab CI brief — competitive landscape report
- New formulation adalimumab updates RSS · CI watch RSS
- AbbVie (prior sponsor, Abbott) portfolio CI
Frequently asked questions about New formulation adalimumab
What is New formulation adalimumab?
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Is New formulation adalimumab also known as anything else?
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Related
- Manufacturer: AbbVie (prior sponsor, Abbott) — full pipeline
- Also known as: Humira
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing