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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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Alvotech Lines Up US Biosimilar Approvals After FDA Inspection

Alvotech has revealed details of exactly when it expects to win US FDA approvals for its Teva-partnered Humira and Stelara biosimilars, after an agency reinspection of its manufacturing plant in Reykjavik, Iceland resulted in just a single “readily addressable” Form 483 observation.

Alvotech Gets A Fresh Date For Adalimumab In US

Alvotech has revealed a US FDA goal date of 24 February 2024 for its refiled AVT02 proposed high-concentration interchangeable adalimumab biosimilar rival to Humira, as the firm provided further details of the resubmission – including an expected facility reinspection.

Alvotech Says Adalimumab Story Is ‘Still Being Written’ Ahead Of ‘Critical’ Inspection

With Alvotech once again asking the US FDA to approve its AVT02 high-concentration interchangeable adalimumab candidate after multiple knockbacks, the company says that the opportunity has not passed as the story of Humira biosimilars is “still being written.”

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