Alvotech Updates on Status of US Biologics License Application for AVT04, a Biosimilar Candidate to Stelara (Ustekinumab)
Portfolio Pulse from Benzinga Newsdesk
Alvotech (NASDAQ:ALVO) has received a complete response letter (CRL) from the FDA regarding its Biologics License Application (BLA) for AVT04, a biosimilar candidate to Stelara. The FDA noted certain deficiencies following an inspection of Alvotech's Reykjavik facility. Alvotech plans to resubmit the BLA for AVT04, which would likely trigger a six-month review period.
October 12, 2023 | 8:07 am
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Alvotech's BLA for AVT04 has been delayed due to deficiencies noted by the FDA. The company plans to address these and resubmit the application.
The FDA's complete response letter indicates that there are issues with Alvotech's application that need to be addressed before approval can be granted. This could potentially delay the launch of AVT04, which could have a negative impact on Alvotech's stock in the short term.
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