Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its biosimilar vedolizumab, INTP53 (powder for concentrate for solution for infusion (300mg/vial)), with Takeda’s Entyvio® (vedolizumab).
This follows Intas’ August 2024 CDSCO approval to conduct a Phase 3 clinical study of INTP53 in patients with moderate to severely active ulcerative colitis.
Intas is not the only company to have a vedolizumab biosimilar in development. For example, in September 2024, Alvotech commenced a Phase 3 clinical trial for its vedolizumab biosimilar, AVT16, in moderate to severe ulcerative colitis. In February 2024, Polpharma Biologics announced that its PB016 (vedolizumab) demonstrated pharmacokinetic and pharmacodynamic equivalence to Entyvio®.