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Alvotech announces new BsUFA end date for AVT02 (biosimilar adalimumab)

Dec 22, 2022

Alvotech announced that the FDA has granted a new Biosimilar User Fee Amendment goal date of 13 April 2023 for its AVT02 (biosimilar adalimumab), and that FDA has confirmed that the data provided are sufficient to support a determination of interchangeability, subject to a site reinspection.  Alvotech is licensed to supply AVT02 in the US from 01 July 2023 in accordance with a licence agreement with AbbVie.

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