Alvotech Receives FDA Review for AVT80 Biologics Application

The U.S. Food and Drug Administration (FDA) has accepted Alvotech's Biologics License Application (BLA) for AVT80 for review. AVT80 is a proposed interchangeable biosimilar to vedolizumab (Entyvio®) intended for subcutaneous administration via prefilled syringe and autoinjector.

Under a partnership with Teva Pharmaceutical Industries Ltd., Alvotech is responsible for the development and manufacturing of AVT80, while Teva handles commercialization. This application expands Alvotech's vedolizumab biosimilar program to include subcutaneous presentations, in addition to its previously submitted intravenous version.

Entyvio® is a biologic medicine used to treat adults with moderately to severely active ulcerative colitis and Crohn's disease. The acceptance of the AVT80 BLA for FDA review marks a significant step in Alvotech's biosimilar development, aiming to improve patient access to biologic medicines.

If approved, AVT80 could allow for pharmacy substitution for the reference product without prescriber intervention in the United States, further enhancing the range of treatment options for patients and healthcare providers. Alvotech aims to expand access to biologic medicines in key therapeutic areas.