Posted by Michael Wonder on 12 Oct 2023
Alvotech provides update on status of US biologics license application for AVT04
12 October 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license application for AVT04, a biosimilar candidate to Stelara (ustekinumab).
As expected, the complete response letter noted that certain deficiencies, which were conveyed following the FDA’s inspection of the company’s Reykjavik facility that concluded in March 2023, must be satisfactorily resolved before the application can be approved.
