Complete response letter for AVT 02 ,a high-concentration biosimilar candidate for Humira.- Alvotech

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. No other deficiencies in the application were noted by the FDA. Alvotech provided the FDA comprehensive responses to the inspection observations on April 3, 2023, and is awaiting communication from the agency assessing those responses.

Alvotech’s second BLA for AVT 02, which contains data to support approval as a biosimilar and additional information supporting potential interchangeability designation – remains under review by the FDA, with a Biosimilar User Fee Amendment (BsUFA) goal date of June 28, 2023. Satisfactory outcome of the facility reinspection remains the key requirement for approval.