Posted by Michael Wonder on 22 Dec 2022
Update on US regulatory status of AVT02, Alvotech’s proposed high concentration, interchangeable biosimilar to Humira
22 December 2022 - US FDA has confirmed that the goal date for an approval decision on Alvotech’s license application for AVT02 is 13 April 2023.
Alvotech announced today that the FDA has granted a new Biosimilar User Fee Amendment goal date of 13 April 2023, for Alvotech’s original biologics license application for AVT02 as biosimilar to Humira. Approval of the application requires satisfactory outcome of a re-inspection of Alvotech’s facility in Reykjavik, Iceland. Alvotech is working with the FDA to schedule a re-inspection in the first quarter of 2023.
