Update on u.s. regulatory status of avt02, alvotech's proposed high-concentration, interchangeable biosimilar to humira®

Reykjavik, iceland, dec. 22, 2022 (globe newswire) -- alvotech (nasdaq: alvo), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, announced today that the fda has granted a new biosimilar user fee amendment (bsufa) goal date of april 13, 2023, for alvotech's original biologics license application (bla) for avt02 as biosimilar to humira®. approval of the application requires satisfactory outcome of a reinspection of alvotech's facility in reykjavik, iceland. alvotech is working with the fda to schedule a reinspection in the first quarter of 2023.
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