Alvotech receives FDA acceptance for Entyvio biosimilar application

Alvotech (NASDAQ:ALVO) announced on Monday that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for intravenous administration.

The application is the product of a strategic partnership between Alvotech and Teva Pharmaceutical Industries.

Under the terms of the collaboration, Alvotech manages the development and manufacturing of the biosimilar candidate, while Teva is responsible for commercialization efforts in the United States.

AVT16 is being developed as an interchangeable biosimilar, a designation that, if granted, would allow the product to be substituted for the reference biologic at the pharmacy level without the intervention of the original prescriber, subject to state-level regulations.

The BLA submission includes a comprehensive data package comprising analytical, pharmacokinetic, and immunogenicity data designed to demonstrate biosimilarity to the reference product, Entyvio, which is widely used to treat adults with moderately to severely active ulcerative colitis and Crohn’s disease.

A key component of the clinical data is the successful completion of a pivotal pharmacokinetic study for AVT80, another Entyvio biosimilar candidate in Alvotech’s pipeline.

According to the company, regulatory guidance confirmed that this study serves as pivotal evidence to support the clinical similarity for both AVT16 and AVT80.

While AVT16 moves through the regulatory review process, it remains an investigational product and has not yet received approval in any market.