Alvotech

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.

Alvotech (NASDAQ: ALVO) will hold its 2025 Annual General Meeting on June 25 in Reykjavik, with virtual access available. Shareholders will review governance updates, financial results, and strategies to bolster its position in the biosimilars market, projected to yield $50 billion in global savings by 2027. Key discussions include expanding its biosimilar pipeline, regulatory progress in the U.S. and Europe, and addressing pricing challenges and patent cliffs. Analysts highlight priorities like commercial partnerships, scalable manufacturing, and differentiation in immunology and oncology. The meeting may signal strategic shifts as Alvotech navigates evolving FDA regulations and leverages biosimilars to counter pharmaceutical revenue declines, emphasizing speed-to-market and cost efficiency.