On 5 February 2026, Alvotech announced positive results from a pharmacokinetic study for AVT80, biosimilar to Takeda’s Entyvio® (vedolizumab).
The Phase 1 study evaluated the comparative pharmacokinetics, safety, immunogenicity and tolerability between AVT80 and Entyvio® in 385 healthy adults. The trial met all the primary endpoints and demonstrated the pharmacokinetic similarity for both the subcutaneous and intravenous routes of administration of the vedolizumab biosimilar when compared with Entyvio®. Alvotech is planning regulatory submissions based on the results of the study.
Alvotech is currently developing two biosimilars to Entyvio®, AVT16 for intravenous administration, and AVT80 for subcutaneous administration. Alvotech commenced a Phase 3 clinical trial for AVT16 in September 2024 in moderate to severe ulcerative colitis.
Other vedolizumab biosimilars in development include Intas’ INTP53 (approval to conduct Phase I bioequivalence study received in February 2025) and Polpharma Biologics’ PB016 (licensing agreement with MS Pharma signed in September 2025 for MENA region). In January 2026, Samsung Bioepis announced that it has added a vedolizumab biosimilar to its pipeline.