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Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab

Apr 13, 2023

Alvotech announced that it received (in March) and responded to (in April) a complete response letter from the FDA regarding its BLA for high concentration (buffer free) formulation of AVT02, biosimilar to AbbVie’s Humira®, and is awaiting the FDA’s assessment of its response.

Alvotech has filed a second BLA for AVT02, which contains data to support approval as a biosimilar with interchangeability designation.  This remains under review by the FDA, with a BsUFA date of 28 June 2023.

Satisfactory outcome of the facility reinspection remains the key requirement for approval of both ABLAs.