Regulatory Update on Alvotech’s AVT02, a High-Concentration Interchangeable Adalimumab Biosimilar

On September 20, Alvotech announced that FDA has accepted the resubmission of its Biologics License Application (BLA) for AVT02, a high concentration, interchangeable biosimilar to HUMIRA (adalimumab). FDA has set a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA of February 24, 2024.  As we’ve previously reported, AVT02 has been approved in Australia as CIPTUNEC and ARDALICIP; in the EU, Norway, Iceland, Lichtenstein, the UK, Switzerland as HUKYNDRA; and in Canada and Saudi Arabia as SIMLANDI.