Oaktree Acquisition's Merging partner Alvotech Announces FDA Accepts Its BLA Supporting Interchangeability For ATV02, A High Concentration, Citrate-Free Biosimilar Candidate For Humira
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 the U.S. Food and Drug Administration (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. The data are from a randomized study (AVT02-GL-302; NCT04453137) in patients that demonstrate bioequivalence of repeated switches between administration of Humira and AVT02 to administration of Humira without switching. As previously announced, no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference product cohort.
The U.S. FDA has communicated a goal date of December 2022 to reach a decision on the BLA.
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 the 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.
"We believe the potential combination of interchangeability with our high-concentration strength of AVT02 reflects a proactive approach to biosimilar development as well as our commitment to patients," said Robert Wessman, Founder and Chairman of Alvotech.
"Achieving interchangeability for AVT02 would be a key enabler in our mission to deliver on our commitment to the sustainability of healthcare systems," said Mark Levick, CEO of Alvotech.
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.1
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 restrictions. Alvotech continues to work with the FDA to coordinate the required inspection(s). Currently, inspections have been scheduled for the requisite facilities and are expected to occur in Q1 and Q2 of 2022.