An Expert Report on AVT-16: Clinical Development, Mechanism of Action, and Strategic Market Positioning of a Vedolizumab Biosimilar

Executive Summary

This report provides a comprehensive analysis of AVT-16, an investigational human monoclonal antibody developed by the global biotechnology company Alvotech. AVT-16 is a proposed biosimilar to Takeda's blockbuster reference product, Entyvio® (vedolizumab), a leading therapy for inflammatory bowel disease (IBD). The primary objective of the AVT-16 program is to establish biosimilarity, thereby offering a cost-effective alternative to Entyvio® and increasing patient access to this critical treatment modality.

The scientific foundation of AVT-16 lies in its mechanism of action as a gut-selective α4β7 integrin antagonist. By specifically binding to the α4β7 integrin on a subset of memory T-lymphocytes, AVT-16 blocks their interaction with the Mucosal Addressin Cell Adhesion Molecule-1 (MAdCAM-1) on endothelial cells within the gastrointestinal tract. This targeted inhibition prevents the migration of inflammatory leukocytes into the gut tissue, addressing the underlying pathophysiology of Ulcerative Colitis (UC) and Crohn's Disease (CD) while avoiding the broader systemic immunosuppression associated with older therapies. This gut-selectivity is a key differentiator, contributing to a favorable safety profile that has been instrumental in the commercial success of the reference product.