Alvotech Begins Confirmatory Patient Study for AVT16, Entyvio Biosimilar Candidate
Biotechnology company Alvotech has initiated a confirmatory patient study for AVT16, a biosimilar candidate targeting Entyvio® (vedolizumab), aiming to demonstrate comparable efficacy and safety.
Reykjavik – Biotechnology company Alvotech announced on September 25, 2024, the initiation of a confirmatory patient study for AVT16, a biosimilar candidate to Entyvio® (vedolizumab). The study aims to demonstrate comparative efficacy, safety, and immunogenicity between AVT16 and Entyvio in patients with moderate to severe active ulcerative colitis.
Alvotech is one of two companies known to have initiated a global or multi-country confirmatory patient study for an Entyvio biosimilar candidate. Sales of Entyvio were approximately $5.4 billion globally in the 12 months leading up to June 30, 2024. The drug is indicated for the treatment of ulcerative colitis and Crohn's disease.
Ulcerative colitis causes inflammation and ulcers in the lining of the bowel, while Crohn's disease causes inflammation of the digestive tract. "We are proud to be able to initiate the confirmatory patient study for AVT16," stated Joseph McClellan, Chief Science Officer of Alvotech. The company's current biosimilar portfolio targets autoimmune diseases, eye disorders, bone disease, respiratory disease, and cancer.
Two biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), are already approved and marketed in multiple global regions. Alvotech anticipates filing marketing applications for three biosimilar candidates in 2024.