Posted by Michael Wonder on 14 Apr 2023
Alvotech provides regulatory update on AVT02 biologics license application
13 April 2023 - Alvotech announced today that the US FDA has issued a complete response letter for Alvotech’s biologics license application for AVT02, a high-concentration biosimilar candidate for Humira (adalimumab).
The complete response letter noted that certain deficiencies, which were conveyed following the FDA’s re-inspection of the company’s Reykjavik facility that concluded on 17 March 2023, must be satisfactorily resolved before the application can be approved.
