Alvotech’s hopes of obtaining US approval for an interchangeable high-concentration adalimumab biosimilar in April hinge entirely on a successful US Food and Drug Administration facility reinspection, expected by March, the company has confirmed, revealing that the FDA had now provided assurances that the AVT02 candidate could be approved as interchangeable based on data provided in the firm’s US filing.
FDA Promises Interchangeability For Alvotech’s 100mg/ml Humira Rival – If It Passes Inspection
April 2023 Approval For AVT02 Adalimumab Biosimilar Hinges On Facility Nod
Alvotech has been bolstered by a US FDA confirmation that its AVT02 adalimumab candidate can be approved as an interchangeable biosimilar based on the data provided in its filing – but first, the Icelandic firm must pass an upcoming facility inspection.
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