Alvotech Welcomes EU Endorsement Of Higher-Strength Adalimumab
Emphasizes Global Approach As Action Still Awaited From US FDA On AVT02 Humira Rival
Alvotech has highlighted the significance to its global development strategy of the EU’s recent approval of its AVT02 higher-strength adalimumab biosimilar. However, one month on from approval, European marketing partner Stada has yet to confirm launch plans.
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Alvotech and its strategic partner Stada are preparing to launch their higher-strength adalimumab candidate AVT02 in Europe after settling intellectual property disputes with originator AbbVie.
Germany’s Stada completed on several strategic milestones in 2021, including launches, approvals and filings for its burgeoning biosimilars business. Reporting financial results for 2021, Stada disclosed the latest on plans to submit partner Xbrane’s ranibizumab biosimilar with the US FDA.
Alvotech and AbbVie have settled all of their legal disputes over Alvotech’s AVT02 biosimilar rival to Humira. With Alvotech seeking a coveted interchangeability designation for its higher-strength adalimumab, the firm’s US entry date provided by the settlement matches that of Boehringer Ingelheim’s interchangeable Cyltezo lower-strength adalimumab biosimilar.