Alvotech completes FDA inspection at Iceland facility

Alvotech (NASDAQ: ALVO) announced that the U.S. Food and Drug Administration completed a routine cGMP surveillance inspection of the company's manufacturing facility in Reykjavik, Iceland.

The FDA issued a Form 483 at the conclusion of the inspection on May 8. Alvotech stated the observations can be addressed quickly and do not raise substantial issues with the site or its operations.

The biotechnology company said it remains positioned to resubmit relevant Biologics License Applications in the second quarter once final data have been compiled. The company continues to expect FDA approval for the relevant BLAs during 2026.

Alvotech develops and manufactures biosimilar medicines. The company has five biosimilars already approved and marketed in multiple global markets, including biosimilars to Humira, Stelara, Simponi, Eylea and Prolia/Xgeva.

The information is based on a company press release.

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