Alvotech Shares Slide on FDA Demands for Application for Arthritis Drug Biosimilar
By Nicholas G. Miller
Shares of Alvotech slid after the Food and Drug Administration sent a complete response letter saying the company would have to resolve certain deficiencies before it could receive approval for its biosimilar candidate to Simponi, a drug to treat rheumatoid arthritis.
The stock fell 24% to $5.83 and is down 56% so far this year.
The letter said that certain deficiencies, which were previously conveyed following the FDA"s inspection of Alvotech's Reykjavik manufacturing facility, would have to be resolved before the company's application for its biosimilar, called AVT05, could be approved.
As a result of the letter, the company lowered its 2025 revenue forecast to $570 million to $600 million, down from its previous guidance of $600 million to $700 million. Analysts see full-year revenue of $662.3 million, according to FactSet.
Write to Nicholas G. Miller at nicholas.miller@wsj.com.
(END) Dow Jones Newswires
November 03, 2025 10:14 ET (15:14 GMT)
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