Alvotech AVT16 BLA accepted by U.S. Food and Drug Administration

Alvogen>>> announced that the United States — Food and Drug Administration>>> has accepted for review its Biologics License Application (BLA) for AVT16. AVT16 is a proposed interchangeable biosimilar to Vedolizumab (vedolizumab), a biologic medicine used to treat ulcerative colitis and Crohn's disease. This acceptance marks a significant step in Alvogen>>>'s mission to expand access to biologic medicines globally. Under a partnership, Alvogen>>> is responsible for the development and manufacturing of AVT16, while Sun Pharma>>> handles its commercialization. The BLA submission is supported by comprehensive data demonstrating biosimilarity. If approved, AVT16 could be substituted for Vedolizumab>>> at pharmacies in the United States>>> without prescriber intervention. Alvogen>>> also previously announced positive results from a pharmacokinetic study for AVT80, another proposed biosimilar to Vedolizumab for subcutaneous administration, which is considered pivotal for both AVT16 and AVT80. The European Union — European Medicines Agency>>> has also validated a Marketing Authorization Application for both AVT16 and AVT80 in the European Union>>>.