Alvotech Shares Rise 20% After FDA Grants AVT02 Goal Date

By Chris Wack

Alvotech shares were up 20% to $9.93 Thursday after the company said the U.S. Food and Drug Administration granted a new Biosimilar User Fee Amendment goal date of April 13, 2023, for Alvotech's Biologics License Application for AVT02 as biosimilar to Humira.

The approval of the application requires a satisfactory reinspection of Alvotech's facility in Reykjavik, Iceland, Alvotech said. Alvotech is working with the FDA to schedule the reinspection in the first quarter of 2023.

The company said communications from the FDA regarding its application supporting interchangeability of AVT02, including a Complete Response Letter received Tuesday, confirmed that the application review is complete. The key requirement for approval is the same as for the original BLA, which is a satisfactory outcome of the facility reinspection.

Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd., is Alvotech's exclusive strategic partner for the commercialization of AVT02 in the U.S.

Write to Chris Wack at [e-mail]

(END) Dow Jones Newswires

December 22, 2022 12:46 ET (17:46 GMT)

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