Alvotech Says FDA Agreed to Review Application for Biosimilar of Entyvio; Shares Rise Pre-Bell
Alvotech (ALVO) said Monday the US Food and Drug Administration has agreed to review its licensing application for a proposed interchangeable biosimilar to the biologic medicine Entyvio for the treatment of ulcerative colitis and Crohn's disease.The company is responsible for developing, as well as producing the medication, while Teva Pharmaceutical (TEVA) oversees market distribution, the company said.The submission has testing data to provide the biological equivalence between the proposed alternative therapy and the original.A prior trial testing a separate variation of the treatment successfully achieved all primary targets to serve as the core clinical similarity evidence for both formulations.Shares of Alvotech added more than 4% in Monday premarket activity.Price: $3.71, Change: $+0.17, Percent Change: +4.90%