Posted by Michael Wonder on 19 Nov 2020
Alvotech announces that the U.S. FDA and EMA have accepted regulatory submissions for AVT02, a proposed biosimilar to Humira (adalimumab)
19 November 2020 - Alvotech is developing AVT02 as a proposed biosimilar to Humira (adalimumab) with high concentration (100 mg/mL) dosage forms.
Alvotech today announced that its U.S. subsidiary Alvotech USA Inc. has filed a biologics license application for AVT02 to the U.S. FDA, which has been accepted for review. The FDA is expected to decide on the filing in September 2021.
Additionally, the EMA has accepted for review a marketing authorisation application for AVT02 with an EMA decision anticipated in the fourth quarter of 2021.
