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5.2

FDA concludes inspection of Alvotech manufacturing facility in Iceland

The U.S. FDA has finished its inspection of Alvotech's Reykjavik production site, which took place in May. The outcome of the inspection remains undisclosed, leaving the status of pending biosimilar approvals uncertain.

Dagens Industri1 day agoIS, USCredibility 27%View source

Score Breakdown

Mosaic Score5.2
Confidence0.9
Significance0.5
Source credibility0.3

Intelligence Tags

#fda#alvotech#biosimilars#pharmaceuticals#regulation

Locations

Reykjavik

Entities

country
Source

Related signals

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