India’s Medical Dialogues reports that Intas Pharmaceuticals has received the Central Drug Standard Control Organisation’s (CDSCO) approval to conduct a Phase III clinical study to compare the efficacy, safety, immunogenicity and pharmacokinetics of its proposed vedolizumab biosimilar, INTP53, for induction and maintenance therapy in patients with moderate to severely active ulcerative colitis.
Takeda obtained FDA approval of Entyvio® (vedolizumab) for ulcerative colitis in September 2023, and more recently (in April 2024) has received FDA approval for subcutaneous administration of Entyvio® (vedolizumab).