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Alvotech Lines Up FDA Inspection Ahead Of Adalimumab Action

Reinspection Of Reykjavik Plant Scheduled For 6 March, Ahead Of 13 April Goal Date

 
• By Dave Wallace

Alvotech has secured a US FDA reinspection of its Reykjavik plant in March, ahead of the agency’s April goal date for action on the firm’s pending application for a high-concentration, interchangeable adalimumab biosimilar rival to Humira.

6 March calendar date with red pin
An FDA inspection of the Reykjavik plant is scheduled for 6 March • Source: Shutterstock

Biosimilars developer Alvotech has received a favorable update from the US Food and Drug Administration indicating that the agency will re-inspect the firm’s Reykjavik facility well ahead of an April FDA goal date for Alvotech’s AVT02 proposed interchangeable high-concentration adalimumab biosimilar.

Alvotech’s filing for the biosimilar had previously been held up by a complete response letter from the FDA

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