Drugs / AVT16
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed | US (FDA) | — | ulcerative colitis | 2026-06-08 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16” alvotech.com ↗ |
| Filed | EU (EMA) | — | ulcerative colitis | 2026-05-06 | “Post-period end: Submitted a Marketing Authorization Application to the European Medicines Agency for AVT16 and AVT80, proposed biosimilars to Entyvio® (vedolizumab)” alvotech.com ↗ |
Trials 2
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 11 trial | ||||||
| Phase 1 | NCT06400719 | May → Nov 2024 | — | Alvotech Swiss AG | Completed | No outcome recorded |
| Phase 31 trial | ||||||
| Phase 3 | NCT06570772 | Sep 2024 → Nov 2025 | ulcerative colitis | Alvotech Swiss AG | Terminated | No outcome recorded Stop: Business |
News releases announcing trial results or a regulatory action · 1
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Alvotech Swiss AG | Regulatory Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio® alvotech.com ↗ |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-06-08 | Alvotech Swiss AG | Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio® alvotech.com ↗ |
| 2024-09-25 | Alvotech Swiss AG | Alvotech Initiates Confirmatory Patient Study for AVT16, a Proposed Biosimilar to Entyvio® alvotech.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 2 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT16 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06570772 ↗ |
| Route | Intravenous | “Single intravenous administration of 300mg of AVT16” NCT06400719 ↗ |