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.

Red and blue wooden figures left out of larger group of yellow figures
Teva and Alvotech will not be able to join the group launching adalimumab biosimilars at the start of July • Source: Shutterstock

More from Biosimilars

More from Products