Posted by Michael Wonder on 21 Sep 2023
Alvotech provides US regulatory update on AVT02, a high concentration interchangeable biosimilar candidate to Humira (adalimumab)
20 September 2023 - Alvotech announced today that the US FDA has accepted Alvotech’s resubmitted biologics license application for AVT02, a high concentration, interchangeable biosimilar candidate to Humira (adalimumab).
The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 biologics license application.
