Alvotech Provides Update On Status Of Biologics License Applications For AVT02 And AVT04
Portfolio Pulse from Benzinga Newsdesk
Alvotech (NASDAQ:ALVO) announced the conclusion of the FDA reinspection of its Iceland facility, receiving a form 483 with one observation. The company expects to respond promptly and believes the issue is addressable, anticipating U.S. approval for biosimilars AVT02 and AVT04 by their respective goal dates, February 24 and April 16, 2024.
January 19, 2024 | 4:31 pm
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Alvotech successfully completed an FDA reinspection with only one observation, which is expected to be addressed promptly. This positions the company for potential approval of AVT02 and AVT04 in the U.S. by the stated goal dates.
The successful conclusion of the FDA reinspection with a minor observation suggests a high likelihood of regulatory approval for Alvotech's biosimilars. This news is directly related to the company's core business and is likely to be viewed positively by investors, potentially leading to a short-term increase in stock price.
CONFIDENCE 80
IMPORTANCE 85
RELEVANCE 100