India, June 8 -- Alvotech (ALVO), a biotechnology company, announced that its Biologics License Application for AVT16, a proposed interchangeable biosimilar to Entyvio (vedolizumab) for intravenous administration, has been accepted for review by the FDA.
According to the company, the Biologics License Application submission is supported by a comprehensive data package and immunogenicity data that demonstrated biosimilarity between AVT16 and its reference product.
AVT16 is an investigational humanized monoclonal antibody which is being formulated as a lyophilized vial that has been validated for marketing authorization application by the European Medicines Agency or EMA along with another compound AVT80 (pre-filled syringe and auto-injecto...