REYKJAVIK, ICELAND--(Business Wire / Korea Newswire) March 10, 2022 -- Alvotech Holdings S.A. (“Alvotech”), a global biopharmaceutical company focused solely on the development and manufacture of biosimilar medicines for patients worldwide, announced today that is has executed a U.S. settlement agreement with AbbVie (NYSE: ABBV) that grants Alvotech non-exclusive rights to market AVT02 (100mg/mL), its high-concentration, citrate-free biosimilar candidate for Humira® (adalimumab) in the United States. The settlement grants Alvotech a license entry date in the United States of July 1, 2023.

The settlement fully resolves all pending U.S. disputes between AbbVie and Alvotech related to AVT02, including the United States International Trade Commission (ITC) case brought forth in December 2021, thus removing any corresponding litigation-related barriers blocking Alvotech’s high-concentration version of adalimumab from reaching U.S. patients.

“We aim to be the first interchangeable, high-concentration biosimilar to this critical treatment,” said Robert Wessman, Founder and Chairman of Alvotech. “We view today as a key milestone for patients and for our mission to fight for healthcare sustainability.”

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. While both low-concentration and high-concentration strengths of Humira are marketed in the U.S. today, over 80 percent of prescriptions are for the high-concentration strengths. In 2021, AbbVie’s sales of Humira topped $20.7 billion, making it the highest grossing pharmaceutical product in the world, excluding COVID-19 vaccines. Teva Pharmaceuticals, a US affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), is Alvotech’s exclusive strategic partner for the commercialization of AVT02 in the United States.

In the U.S., an interchangeable product is a biosimilar product that meets additional requirements outlined by the Biologics Price Competition and Innovation Act. As part of fulfilling these additional requirements, information is needed to show that an interchangeable product is expected to produce the same clinical result as the reference product in any given patient. Also, for products administered to a patient more than once, the risk in terms of safety and reduced efficacy of switching back and forth between an interchangeable product and a reference product will have been evaluated. An interchangeable product may be substituted for the reference product without the involvement of the prescriber.

AVT02 has received approval in Europe, Canada, and the United Kingdom. In the U.S., Alvotech announced in September 2021 that the FDA is deferring action on its BLA that was accepted in November 2020. The FDA can defer action when no deficiencies have been identified and the application otherwise satisfies the requirements for approval, but an inspection(s) is necessary yet cannot be completed due to factors including travel restrictions1. Currently, inspections have been scheduled for the requisite facilities and are expected to occur in Q1 and Q2 of 2022. In February 2022, Alvotech announced that the FDA has accepted for review the company’s Biologics Licensing Application (BLA) for ATV02 (100 mg/mL) that includes new data supporting interchangeability between ATV02 and Humira.