On April 13, 2023, after the market closed, Alvotech issued a press release entitled “Alvotech Provides Regulatory Update on AVT02 Biologics License Application. In this press release, Alvotech announced “that the U.S. Food and Drug Administration (FDA) has issued a complete response letter (‘CRL’) for Alvotech’s Biologics License Application (‘BLA’) for AVT02, a high-concentration biosimilar candidate for Humira® (adalimumab). The CRL noted that certain deficiencies, which were conveyed following the FDA’s reinspection of the company’s Reykjavik facility that concluded on March 17, 2023, must be satisfactorily resolved before the application can be approved.” Alvotech further announced that its second BLA for AVT02 remained under review, and that “satisfactory outcome of the facility reinspection remains the key requirement for approval.

On this news, Alvotech’s stock price fell $3.03 per share, or 22% to close at $10.66 per share on April 14, 2023.