(Updates to add share movement in the headline and the first paragraph.)
Alvotech's (ALVO) shares rose nearly 5% in Monday trading after the company said that its biologics license application for AVT80 as a proposed interchangeable biosimilar to Entyvio was accepted for review by the US Food and Drug Administration.
Entyvio is approved as a treatment for adults with moderately to severely active ulcerative colitis and Crohn's disease, according to the statement. The application is backed by data that demonstrate the biosimilarity between AVT80 and Entyvio.
AVT80 is under a partnership between Alvotech and Teva Pharmaceutical Industries (TEVA), with Alvotech in charge of development and manufacturing and Teva responsible for commercialization, according to the statement.
Price: $5.19, Change: $+0.24, Percent Change: +4.85%