Complete Response Letter
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Alvotech Updates on U.S. BLA for AVT05
Alvotech (ALVO) received a Complete Response Letter from the FDA for its AVT05 biosimilar application, citing deficiencies from a July 2025 facility inspection in Reykjavik. No other application deficiencies were noted, and the facility retains FDA approval for existing product manufacturing. Alvotech submitted a CAPA plan. The company revised its 2025 financial outlook to $570-600 million in revenue and $130-150 million adjusted EBITDA, reflecting facility investments and a temporary production slowdown. US sales of reference product Simponi were <$300M in 1H 2025; no Simponi biosimilar is approved in the US.
