Alvotech says FDA accepts AVT80 biosimilar BLA for review
Reuters2026/08/31 08:31- FDA accepted for review a BLA for AVT80, a proposed interchangeable biosimilar to Entyvio for subcutaneous administration.
- Deal with Teva assigns development and manufacturing to Alvotech; commercialization to Teva.
- Filing covers prefilled syringe and autoinjector presentations.
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