On March 8, 2022, Alvotech announced that it has executed a U.S. settlement agreement with Abbvie that grants Alvotech non-exclusive rights to market AVT02 (adalimumab) in the U.S starting July 1, 2023. AbbVie confirmed the resolution of disputes and stated that Alvotech will take a non-exclusive license to the patents, and in return, pay royalties and acknowledge the licensed patents’ validity. AVT02 is a biosimilar to the high-concentration 100 mg/ml formulation of Humira® (adalimumab). We previously reported on AbbVie’s expansive Humira® patent portfolio asserted against Alvotech’s AVT02 (here). Further, Abbvie filed a Section 337 Complaint before the International Trade Commission (“ITC”), seeking to block imports of Alvotech’s AVT02. With the settlement, all ongoing U.S. disputes, including the ITC action brought in December 2021, between Abbvie and Alvotech related to AVT02 have been fully resolved.
In February 2022, the FDA accepted Alvotech’s Biologics Licensing Application (BLA) for review for AVT02 that includes new data supporting interchangeability between ATV02 and Humira® and stated that it will reach a decision by December 2022. With the final barrier, the ITC action brought by Abbvie, removed, Alvotech can launch its biosimilar product as early as July 1, 2023 (assuming timely FDA approval). Alvotech’s AVT02 is certainly not the only adalimumab biosimilar set to hit the market in 2023. As previously reported in our earlier post, there are at least eight adalimumab biosimilars that are due to launch by the end of 2023 in the U.S., where Abbvie secured over $20 billion of its Humira® sales revenues in 2021. With the launch of adalimumab biosimilar products in Europe in 2018, the sales of Humira® dropped by 30 percent in the following year. Thus, evidence from Europe suggests that biosimilar companies are likely to take a significant portion of Humira®’s U.S. market share with aggressive discounting.
As discussed in our earlier post, AbbVie’s assertion of its “thicket” of adalimumab-related patents against biosimilar manufacturers prompted an unprecedented antitrust suit against AbbVie in which the district court judge ultimately sided with AbbVie, but which was later appealed to the 7th Circuit. The 7th Circuit heard arguments in that case in February 2021, but has not yet issued a decision.
We continue to provide a comparison of the U.S. and Europe on Biosimilar product authorizations and pipeline products. For our most updated version, please visit here.