Alvotech (NASDAQ: ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the reinspection of Alvotech’s facility in Iceland by the U.S. Food and Drug Administration (FDA) which started on January 10, 2024, has been concluded. Following the FDA inspection, Alvotech received a form 483 with one observation. Alvotech expects to provide the FDA with a response in the following days.
“We believe that the observation is readily addressable, and we intend to respond as quickly as possible,” said Robert Wessman, Chairman and CEO of Alvotech.
Based on the conclusion of the facility reinspection, Alvotech believes it is in a position to receive approval in the U.S. for AVT02 and AVT04 by February 24, 2024, and April 16, 2024, their respective goal dates.
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