Alvotech Shares Rise After FDA Approves Additional Manufacturing for Simlandi
By Chris Wack
Alvotech shares rose after the company said the Food and Drug Administration has approved a supplement to the biologics license application for AVT02 adalimumab-ryvk, marketed in the U.S. as Simlandi.
The stock was 13% higher, at $6.18, in midday trade, but is 26% lower in the past 12 months.
The company said the supplement approval enables the product to be manufactured in a second production suite at the company's Reykjavik facility, and effectively doubles the drug substance manufacturing capacity. The additional capacity will support U.S. supply and provide greater flexibility for commercial supply of AVT02 to the U.S. market.
The approval follows the FDA's July closure of its most recent inspection of the Reykjavik facility with a Voluntary Action Indicated classification. Alvotech expects the FDA to be able to take action on other pending applications associated with the facility still outstanding.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
October 05, 2026 12:49 ET (16:49 GMT)
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