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Alvotech (ALVO) Is Down 38.6% After FDA Delays AVT05 .... In November 2025, Alvotech announced that the U.S. FDA issued a complete response letter for the Biologics License Application of AVT05, a biosimilar to Simponi, highlighting deficiencies in the Reykjavik manufacturing facility that must be resolved before approval, though the site remains FDA-approved for current products. The delay in AVT05’s approval prompted Alvotech to lower its 2025 ...
Alvotech (NASDAQ:ALVO) is a global biopharmaceutical company specializing in the development, manufacturing and commercialization of biosimilar medicines. The company focuses on creating high‐quality, cost‐effective alternatives to established biologic therapies in areas such as immunology, oncology and other specialty care fields.
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