By Dean Seal

Shares of Alvotech jumped after the company said its drug candidates AVT02 and AVT04 could be approved in the coming months now that U.S. regulators have concluded their inspection of its Iceland facility.

The stock was up 11% at $13.60 in early trading. Shares are now up more than 16% since the start of the year.

The biotech company said Friday that the U.S. Food and Drug Administration has completed its facility reinspection and submitted just one observation to Alvotech, which the company expects to respond to in the days to come.

"We believe that the observation is readily addressable, and we intend to respond as quickly as possible," Chief Executive Robert Wessman said.

Based on the conclusion of the reinspection, Alvotech believes it is positioned to receive approval in the U.S. for AVT02, a biosimilar candidate to Abbvie's Humira, by Feb. 24 and for AVT04, a biosimilar to Janssen Pharmaceuticals' Stelara, by April 16.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

January 19, 2024 12:16 ET (17:16 GMT)

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