Biosimilar

Alvotech has settled with Regeneron, clearing a path for its biosimilar AVT06 (aflibercept) to potentially enter the U.S. market in late 2026, pending FDA approval. This agreement, alongside a partnership with Teva Pharmaceuticals, follows AVT06’s recent marketing approvals in the UK, Japan, and the EEA. Clinical studies have confirmed AVT06’s high degree of similarity to Eylea®, positioning it as a more affordable alternative for retinal diseases.

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.