On 19 January 2024, an Alvotech-sponsored study, published in the Sage Journal, concluded on the basis of a “totality of evidence approach” that there was no clinically meaningful difference between Alvotech’s AVT02 (adalimumab biosimilar) and AbbVie’s Humira® (adalimumab). The study found that there were minor differences in a few physiochemical attributes, however, that did not impact the in vitro biologic activity and therefore this difference was ruled out and not considered clinically relevant.
On 23 February 2024, FDA approved Alvotech’s SIMLANDI® (AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira® after which Alvotech’s U.S listed shares rose more than 12% to $18 in pre-market trading.