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

Feb 28, 2022

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.