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Alvotech Provides U.S. Regulatory Update on AVT02, a High-Concentration Interchangeable Biosimilar Candidate to Humira® (adalimumab)
REYKJAVIK, Iceland, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and
About this update from Alvotech
[{"type":"text","content":"REYKJAVIK, Iceland, Sept. 20, 2023 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the U.S. Food and Drug Administration (FDA) has accepted Alvotech’s resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar candidate to Humira® (adalimumab). The FDA has also announced a Biosimilar User Fee Act (BsUFA) goal date for approval of the resubmitted AVT02 BLA. The BsUFA goal date provided by the FDA is February 24, 2024. The FDA indicated that Alvotech’s resubmission is considered to be a complete response to the agency’s June 28, 2023, action letter, given the additional Chemistry, Manufacturing and Controls information submitted by the Company with the BLA to address manufacturing facility deficiencies identified earlier by the FDA. “We remain committed to bringing AVT02 to patients in the U.S., where the need for a high-concentration, interchangeable biosimilar to Humira remains significant and unmet,” said Robert Wessman, Chairman and CEO of Alvotech. “No deficiencies in our BLA have been noted by the FDA other than those associated with our facility. We now await further guidance from the FDA on timing of a reinspection, which we expect to occur in advance of the BsUFA date.” An interchangeable biosimilar may be substituted at the pharmacy without the intervention of the healthcare professional who prescribed the originator biologic, subject to variations in state pharmacy laws and practices. No interchangeable high-concentration adalimumab biosimilar is currently available to U.S. patients. About AVT02 (adalimumab)AVT02 is a monoclonal antibody and that has been approved as a biosimilar to Humira® (adalimumab) in several countries globally, including the 27 member states of the European Union, Norway, Lichtenstein, Iceland, the UK, Switzerland, Canada, Australia, Egypt and Saudi Arabia. It is currently marketed in multiple European countries and in Canada. Dossiers are also under review in multiple countries globally. About Alvotech Alvotech is a biotech company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in...