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Alvotech and Teva reach settlement and licence agreement with J&J for AVT04, biosimilar to Stelara® (ustekinumab)

Jun 12, 2023

Alvotech and Teva announced they have reached a settlement and license agreement with Johnson & Johnson for AVT04, Alvotech’s biosimilar to Stelara® (ustekinumab).  J&J have granted a license entry date for AVT04 in the US no later than 21 February 2025. This is seven weeks after the reported date by which Amgen will be able to enter the market (1 January 2025) pursuant to its recent settlement with J&J.

On 6 January 2023, the FDA accepted the BLA for AVT04.