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Alvotech’s Resubmits BLA for AVT02, Interchangeable Biosimilar to AbbVie’s Humira® Accepted by FDA

Sep 20, 2023

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024.  Alvotech stated that the FDA indicated that the resubmission, which incorporated  additional Chemistry, Manufacturing, and Controls information, is considered to be a completed response to the FDA’s Complete Response Letter (CRL) of 28 June 2023.  Alvotech announced on 13 April 2023 that it had responded to an earlier CRL received in March 2023.

On 31 August 2023, Alvotech announced that it had resubmitted the BLA for AVT02 to the FDA but did not disclose details or the BsUFA goal date.