Alvotech Shares Rise 20% After FDA Grants AVT02 Goal Date
23 December 2022 - 05:01AM
Dow Jones News
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 chris.wack@wsj.com
(END) Dow Jones Newswires
December 22, 2022 12:46 ET (17:46 GMT)
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