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
Executive Summary
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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