Alvotech says FDA accepts AVT80 biosimilar BLA for review
ALVO•FDA accepts AVT80 BLA for review
- 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.
