"A Key Milestone for patients"

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.

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.

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.