The FDA is expected to issue draft guidance reducing testing requirements for biosimilar drugs, potentially lowering development costs by USD 20 million. The move comes as the biosimilars market shows strong growth, with major launches in 2025.
Abivax announced novel preclinical and clinical data for obefazimod at ECCO 2026, highlighting anti-fibrotic potential in Crohn's disease, favorable safety profile, and rapid onset of symptomatic relief in inflammatory bowel disease patients.
| NCT ID | Title | Status | Phase |
|---|---|---|---|
| NCT06786910 |
Effect on Cytokines IL-1ß, TNF-α, IL-4, and Total Bacterial Load of a Composition Comprising Olive Oil, Trimethylglycine and Xylitol Delivered as a Toothpaste |
COMPLETED | NA |
| NCT00976729 |
NOX-E36 First-in-Human (FIH) Study |
COMPLETED | PHASE1 |
| NCT00721097 |
Predictive Factors for Exacerbation Outcome in Severe Refractory Asthmatics |
TERMINATED |
