By: IPP Bureau
Last updated : March 09, 2022 12:43 pm
Alvotech expects AVT02 (adalimumab) will be marketed in the U.S., subject to regulatory approval, on July 1, 2023
Alvotech has executed a U.S. settlement agreement with AbbVie 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.
“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 US $ 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 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.