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Home » FDA Issues CRL to Alvotech Over BLA for Humira Biosimilar Candidate
FDA Issues CRL to Alvotech Over BLA for Humira Biosimilar Candidate
Alvotech has drawn an FDA Complete Response Letter (CRL) for manufacturing facility deficiencies in its BLA for AVT02, a biosimilar candidate for AbbVie’s mega-blockbuster anti-inflammatory therapy Humira (adalimumab).