Alvotech And Teva To Miss US Adalimumab Launch After Further FDA Setback
Firms Get Another CRL Over AVT02 High-Concentration Interchangeable Biosimilar
FDA approval for Alvotech and Teva’s AVT02 adalimumab biosimilar has once again failed to materialize as the agency issued another CRL over the product. The setback means the firms will miss their projected launch date of 1 July and will not be part of the pack launching multiple Humira rivals in the coming weeks.