Alvotech provides update on FDA action regarding AVT 02, proposed high-concentration biosimilar to Humira.
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.
Alvotech is the only known company that has both submitted a Biologics License Application (BLA) for a high-concentration biosimilar candidate to Humira, the most commonly utilized strength of the product on the market, and has successfully conducted a switching study in support of an FDA designation of interchangeability and correspondingly the potential for product substitution at the pharmacy level. Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. is the exclusive strategic partner for the commercialization of AVT 02 in the United States.
European rights are licensed to Stada Arzneimittel AG.
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