Alvotech Holdings S.A. (“Alvotech”) has announced that they have settled all pending disputes between AbbVie and Alvotech related to AVT02 (100mg/mL), Alvotech’s high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab). The announcement states that under the settlement agreement, Alvotech has non-exclusive rights to market AVT02 in the United States starting July 1, 2023. According to the announcement: “Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and conducted a switching study, to support potential approval as an interchangeable product.”  The announcement further states that FDA has deferred action on Alvotech’s BLA until necessary inspections are completed.  AVT02 is approved in Europe, Canada, and the United Kingdom.

We have previously reported on the litigations between Alvotech and AbbVie with posts on litigation updates, Abbvie’s allegations of trade secret misappropriation, AbbVie’s second suit for patent infringement, and Alvotech’s related suit against AbbVie, and AbbVie’s suit against Alvotech before the United States International Trade Commission.