Posted by Michael Wonder on 20 Sep 2021
Alvotech provides update on FDA action regarding AVT02, proposed high concentration biosimilar to Humira (adalimumab)
20 September 2021 - Alvotech today announced that the FDA is deferring action on the application for AVT02, the company’s proposed biosimilar to Humira, until facility assessments can be completed.
The FDA can defer action when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions.
Alvotech continues to work with the FDA to coordinate the required inspection(s) in a safe and adequate manner.
Teva Pharmaceuticals is the exclusive strategic partner for the commercialisation of AVT02 in the United States.
