AVT-80 (vedolizumab biosimilar) / Alvotech, Teva - LARVOL DELTA

PHARMACOKINETIC SIMILARITY OF CANDIDATE BIOSIMILAR AVT80 AND REFERENCE PRODUCT VEDOLIZUMAB (UEGW 2026) - No abstract available

PK/PD data • Gastroenterology • Gastrointestinal Disorder • Immunology • Inflammatory Bowel Disease

Alvotech Announces FDA Acceptance for Review of Biologics License Application for AVT80, Expanding Proposed Biosimilar Program for Entyvio to Subcutaneous Presentations (GlobeNewswire) - "The BLA submission is supported by a comprehensive data package, including analytical, pharmacokinetic, and immunogenicity data generated to support the demonstration of biosimilarity between AVT80 and the reference product....In February 2026, Alvotech announced positive results from a pivotal pharmacokinetic study for AVT80."

FDA filing • Immunology

Alvotech Reports Positive Top-line Pharmacokinetic Study Results For AVT80, A Biosimilar To Entyvio (Nasdaq) - "Alvotech (ALVO) has reported that its pivotal pharmacokinetic study for AVT80- its proposed biosimilar to Takeda Pharma's Entyvio - met all primary endpoints....The pivotal pharmacokinetic (PK) study, AVT80-GL-P01, was a randomized, double-blind, single-dose trial conducted in healthy adults. It compared AVT80 with the reference product and demonstrated pharmacokinetic similarity, supported by aligned safety, tolerability, and immunogenicity profiles."

P1 data • PK/PD data • Immunology

AVT80-GL-P01: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio (clinicaltrials.gov) - P1 | N=385 | Completed | Sponsor: Alvotech Swiss AG | Active, not recruiting ➔ Completed

Trial completion

AVT80-GL-P01: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio (clinicaltrials.gov) - P1 | N=351 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Trial completion date: Oct 2025 ➔ Jan 2026 | Trial primary completion date: Oct 2025 ➔ Jan 2026

Trial completion date • Trial primary completion date

AVT80-GL-P01: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio (clinicaltrials.gov) - P1 | N=351 | Active, not recruiting | Sponsor: Alvotech Swiss AG | Recruiting ➔ Active, not recruiting

Enrollment closed

AVT80-GL-P01: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio (clinicaltrials.gov) - P1 | N=351 | Recruiting | Sponsor: Alvotech Swiss AG | Not yet recruiting ➔ Recruiting

Enrollment open

AVT80-GL-P01: Study to Investigate Comparative Pharmacokinetics, Safety, Immunogenicity and Tolerability Between AVT80 and Entyvio (clinicaltrials.gov) - P1 | N=351 | Not yet recruiting | Sponsor: Alvotech Swiss AG

New P1 trial