RegulatoryJul 29, 2026, 09:38 AM
Alvotech FDA Inspection of Iceland Facility Closed with VAI
AI Summary
Alvotech announced that the U.S. Food and Drug Administration (FDA) has closed its inspection of the company's manufacturing facility in Reykjavik, Iceland, with a Voluntary Action Indicated (VAI) classification. This outcome signifies that no official action is indicated by the FDA. CEO Lisa Graver expressed confidence that the company's actions have effectively addressed previous observations, and Alvotech continues to work with the FDA on advancing its Biologics Licence Applications for biosimilar candidates like AVT05, AVT06, and AVT16.
Key Highlights
- FDA closed inspection of Alvotech's Reykjavik manufacturing facility, conducted in May 2026.
- Inspection classification for the manufacturing site is Voluntary Action Indicated (VAI).
- CEO Lisa Graver stated confidence that actions addressed observations.
- Company continues to work with FDA to advance Biologics Licence Applications (BLAs).
- Resubmitted BLAs for AVT05 (Simponi biosimilar) and AVT06 (Eylea biosimilar).
- FDA accepted BLA for AVT16 (Entyvio biosimilar) in June 2026.
Price Impact
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