Alvotech’s Ustekinumab Passes Safety And Efficacy Milestone
Company Reports Fresh Data For AVT04 Biosimilar Rival To Stelara
Alvotech has announced success in its confirmatory clinical safety and efficacy study for its AVT04 ustekinumab candidate, a proposed biosimilar to Stelara.
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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.
Recently public Alvotech had much to share as part of its nine-month financial report, including updates on adalimumab in the US and the process to begin biosimilar golimumab trials.
Tipped to bring in revenues from its proposed Stelara biosimilar of $600m in 2027, Alvotech has confirmed plans for a potentially landmark filing with major regulators by the end of the year.