Alvotech announces FDA acceptance for review of Biologics License Application for AVT80, expanding proposed biosimilar program for Entyvio® to subcutaneous presentations
Alvotech announced that the U.S. FDA has accepted for review a Biologics License Application for AVT80, a proposed interchangeable biosimilar to Entyvio (vedolizumab) in prefilled syringe and autoinjector forms for subcutaneous administration. This expands Alvotech's proposed biosimilar program for Entyvio to subcutaneous presentations.
Why it matters — The FDA acceptance marks progress in Alvotech's biosimilar development efforts and broadens its proposed Entyvio biosimilar program to include subcutaneous presentations, a development of interest to Alvotech watchers.