FDA accepts Alvotech’s license application for Entyvio biosimilar candidate
The U.S. Food and Drug Administration has accepted for review Alvotech’s application for AVT16, a proposed interchangeable biosimilar to the inflammatory bowel disease drug Entyvio.
The U.S. Food and Drug Administration (FDA) has accepted a Biologics License Application (BLA) from Alvotech for AVT16, a biosimilar candidate designed to compete with the reference product Entyvio (vedolizumab). The product is intended for intravenous administration in patients suffering from moderately to severely active ulcerative colitis and Crohn’s disease.
The development and manufacturing of AVT16 are managed by Alvotech, while Teva Pharmaceutical Industries oversees commercialization under a partnership agreement. The filing is supported by analytical, pharmacokinetic, and immunogenicity data intended to demonstrate the biosimilarity of the candidate to the original biologic.
By filing for interchangeability, Alvotech seeks to allow pharmacists to substitute the biosimilar for the reference product without physician intervention, subject to state laws. This regulatory milestone follows positive pharmacokinetic study results announced earlier in 2026, which support the clinical similarity for both the intravenous and subcutaneous versions of the drug.
This application represents part of Alvotech's broader strategy to expand its portfolio in immunology and gastrointestinal medicine. The company aims to increase market access to biologic treatments as patents for various reference products expire.