Alvotech Reports Pharmacokinetic Equivalence of AVT05 to Entyvio in Pivotal Study

Alvotech has released the top-line results from its pivotal pharmacokinetic study evaluating AVT05, a proposed biosimilar to Entyvio® (vedolizumab). The study met its primary objectives, demonstrating pharmacokinetic equivalence between AVT05 and the reference product. The findings mark a significant step in Alvotech’s development of biosimilars for autoimmune diseases.

The clinical trial assessed the pharmacokinetics, safety, and tolerability of AVT05 compared to Entyvio®. Researchers conducted the study on healthy volunteers and reported that AVT05 showed comparable bioavailability to the reference product. Additionally, no significant safety concerns or adverse events emerged during the trial. These results support further regulatory submissions as part of Alvotech’s efforts to expand access to biologic treatments through biosimilar development.

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Date: February 5, 2026

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GOAI