Alvotech receives another CRL from the FDA for Humira biosimilar candidate

Biosim­i­lar de­vel­op­er Alvotech has once again been hand­ed a com­plete re­sponse let­ter from the FDA.

On Wednes­day, the com­pa­ny an­nounced that it re­ceived a re­jec­tion for the sec­ond BLA for AVT02, a high-con­cen­tra­tion biosim­i­lar can­di­date for Hu­mi­ra. Ac­cord­ing to Alvotech’s re­lease, the most re­cent ap­pli­ca­tion had more da­ta and in­for­ma­tion at­tached. But the CRL not­ed the agency found “cer­tain de­fi­cien­cies” in its rein­spec­tion of Alvotech’s fa­cil­i­ty in Reyk­javik, Ice­land, in March. These de­fi­cien­cies, the CRL stat­ed, must be ad­dressed be­fore an ap­proval can be grant­ed. Alvotech not­ed that no oth­er is­sues in the ap­pli­ca­tion were not­ed by the FDA.

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