On 18 April 2024, Takeda announced FDA approval of subcutaneous administration of ENTYVIO® (vedolizumab) for maintaining therapy in adults with moderately to severely active Crohn’s disease (CD).
This follows the FDA’s acceptance of Takeda’s BLA for ENTYVIO® for the same indication, and the FDA’s approval of ENTYVIO® for ulcerative colitis (UC), in September 2023.
Vedolizumab biosimilars have previously been reported to be in development by Polpharma Biologics, Alvotech(under an agreement with Advanz) and Bio-Thera.