FDA accepts Alvotech’s BLA data supporting interchangeability for AVT02 (high-concentration (100mg/ml) biosimilar adalimumab)

Alvotech announced that the FDA has accepted the BLA including data supporting interchangeability for AVT02, Alvotech’s high-concentration (100mg/ml) biosimilar adalimumab.  The Biosimilar User Fee Act goal date for FDA decision is December 2022.