Alvotech Humira Settlement Sets Up Interchangeable Adalimumab Showdown
US Launch Date Matches That Of BI’s Cyltezo Interchangeable Humira Biosimilar
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.
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Sandoz is looking to enter the European market for high-concentration adalimumab after announcing EMA acceptance of its filing for a 100mg/ml version of its Hyrimoz biosimilar. Celltrion and Stada/Alvotech already have higher-strength rivals to Humira available in Europe.
Alvotech is celebrating an “historic milestone” as it became a publicly listed company in New York, with its shares set to also trade in its domestic Iceland next week.
Fresh from partner Alvotech resolving patent litigation in the US for its proposed Humira biosimilar, Teva management has detailed the firm’s expectations around the product and the crucial issue of supply.