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Alvotech And Teva File US Stelara Rival Ahead Of 2023 Expiry

Filing For AVT04 Proposed Ustekinumab Biosimilar Is Accepted By US FDA

Executive Summary

Alvotech and marketing partner Teva have confirmed that their AVT04 proposed ustekinumab biosimilar rival to Stelara has been filed with the US FDA, ahead of a key patent expiry later this year.

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Teva and Alvotech have struck a deal with Stelara originator Johnson & Johnson to secure a 21 February 2025 launch date for their AVT04 ustekinumab biosimilar in the US – just over seven weeks after rival Amgen is able to enter the market.

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