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Alvotech Shares U.S. Regulatory Progress on AVT02, a High-Concentration Biosimilar Candidate for Humira® (adalimumab)

Thursday, September 21, 2023

Alvotech, a global biotechnology firm specializing in biosimilar medicines, has made an official announcement regarding the acceptance of its resubmitted Biologics License Application (BLA) for AVT02 by the U.S. Food and Drug Administration (FDA). AVT02 is positioned as a high-concentration, interchangeable biosimilar candidate for Humira® (adalimumab). The FDA has assigned a Biosimilar User Fee Act (BsUFA) goal date for the approval of this resubmitted AVT02 BLA, scheduled for February 24, 2024.

The FDA has confirmed that Alvotech's resubmission addresses the concerns raised in their action letter dated June 28, 2023. The resubmission includes additional information related to Chemistry, Manufacturing, and Controls, specifically addressing manufacturing facility deficiencies previously noted by the FDA.

Robert Wessman, Chairman and CEO of Alvotech, expressed the company's unwavering commitment to making AVT02 accessible to patients in the United States, where there is a substantial, unmet demand for a high-concentration, interchangeable biosimilar to Humira. He emphasized that the FDA has not identified any shortcomings in the BLA aside from those associated with the company's facility. Alvotech is now awaiting further guidance from the FDA concerning the timing of a reinspection, anticipated to occur prior to the BsUFA date.

An interchangeable biosimilar like AVT02 can be dispensed at pharmacies without requiring intervention from the healthcare professional who prescribed the original biologic. This is contingent on state pharmacy laws and practices. Currently, there is no interchangeable high-concentration adalimumab biosimilar accessible to patients in the United States.

AVT02 is a monoclonal antibody approved as a biosimilar to Humira (adalimumab) in multiple countries worldwide, encompassing EU member states, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, Egypt, and Saudi Arabia. AVT02 is currently available in various European nations and Canada, with applications under review in numerous countries across the globe.

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