FDA Review Accepted for Alvotech’s Vedolizumab Biosimilar

Alvotech announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT16, its proposed interchangeable biosimilar to Entyvio® (vedolizumab) for intravenous administration. The filing advances AVT16 toward potential approval as a new treatment option for adults with moderately to severely active ulcerative colitis and Crohn’s disease.

Under Alvotech’s partnership with Teva Pharmaceutical Industries, Alvotech leads development and manufacturing, while Teva will oversee U.S. commercialization. The regulatory milestone marks another step in expanding access to biologic medicines through the company’s growing biosimilar portfolio.

Expanding Access to Vedolizumab Therapy

Vedolizumab, a gut-selective monoclonal antibody targeting the α4β7 integrin, has become an established therapy for inflammatory bowel disease (IBD). By blocking the migration of inflammatory white blood cells into gastrointestinal tissue, the drug reduces intestinal inflammation while limiting systemic immune suppression.

Despite its clinical value, biologic treatment costs can limit patient access. Biosimilars such as AVT16 may improve access by increasing competition in the biologics market. If approved with interchangeability status, AVT16 could be substituted for the reference product at the pharmacy level without prescriber intervention, subject to applicable state pharmacy laws, a distinction that may facilitate broader uptake following approval.

 Evidence Supporting Development

The BLA submission is supported by analytical, pharmacokinetic, and immunogenicity data demonstrating similarity to reference vedolizumab.

The submission also draws on data from AVT80, Alvotech’s proposed subcutaneous vedolizumab biosimilar. In February 2026, a randomized, double-blind, parallel-group study in healthy adults met all primary pharmacokinetic endpoints comparing AVT80 with Entyvio. Based on regulatory guidance, the study is considered pivotal for supporting clinical similarity assessments for both AVT16 and AVT80, potentially streamlining development across intravenous and subcutaneous formulations.

Leadership Perspective

Joseph McClellan, Chief Operating Officer of Alvotech, said the FDA’s acceptance of the application represents an important step in broadening patient access to biologic medicines. He highlighted the company’s integrated biosimilar development and manufacturing platform and its growing immunology portfolio.

Global Outlook and Market Context

AVT16 remains investigational and has not yet received regulatory approval in any market. In Europe, the European Medicines Agency (EMA) has validated a Marketing Authorization Application covering both AVT16, the intravenous formulation, and AVT80, a subcutaneous version available as a prefilled syringe and auto-injector.

The regulatory progress comes as vedolizumab faces increasing biosimilar competition globally, with patent protections for Entyvio expected to expire in key markets later this decade. FDA review of biosimilar applications typically spans approximately 10 months under standard timelines, although review periods may vary.

If approved, AVT16 would strengthen the expanding U.S. biosimilar landscape and provide healthcare professionals and patients with an additional interchangeable treatment option for ulcerative colitis and Crohn’s disease.

Reference

Alvotech announces FDA acceptance of Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio® – Alvotech