Alvotech And Teva File US Stelara Rival Ahead Of 2023 Expiry
Filing For AVT04 Proposed Ustekinumab Biosimilar Is Accepted By US FDA
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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Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).
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.
A settlement reached in US patent litigation over Janssen’s Stelara will allow Amgen to launch its ABP 654 ustekinumab biosimilar no later than 1 January 2025. It remains to be seen whether other ustekinumab developers will follow suit.