Drugs / AVT80
Regulatory milestones approvals, filings & regulatory actions · 2 recorded
| Milestone | Jurisdiction | Brand | Indication | Date | Sentence it was read from |
|---|---|---|---|---|---|
| Filed ulcerative colitis 1 milestone | |||||
| Filed | US (FDA) | — | ulcerative colitis | 2026-08-31 | “today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT80” alvotech.com ↗ |
| Filed Indication not stated 1 milestone | |||||
| Filed | EU (EMA) | — | — | 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 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06732804 | Feb 2025 → Jan 2026 | — | Alvotech Swiss AG | Completed | Met primary |
News releases announcing trial results or a regulatory action · 2
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Alvotech Swiss AG | Regulatory Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations alvotech.com ↗ |
| 2026-02-05 | Alvotech Swiss AG | Results Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio® alvotech.com ↗
Alvotech (NASDAQ: ALVO), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today positive top-line results from a pharmacokinetic (PK) study for AVT80, a biosimilar candidate to Entyvio® (vedolizumab). |
All press releases naming this drug 2 releases
| Date | Issuer | Release |
|---|---|---|
| 2026-08-31 | Alvotech Swiss AG | Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations alvotech.com ↗ |
| 2026-02-05 | Alvotech Swiss AG | Alvotech Announces Positive Top-Line Results from Pivotal Pharmacokinetic Study for Proposed Biosimilar to Entyvio® alvotech.com ↗ |
Evidence & citations 2 cited values
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | AVT80 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06732804 ↗ |
| Route | Subcutaneous | “Single subcutaneous injection of AVT80 (108mg)” NCT06732804 ↗ |