On July 22, 2024, STADA Arzeimittel AG (“STADA”) and Alvotech announced the launch of ustekinumab biosimilar AVT04 under the name UZPROVO® across a majority of European countries. UZPROVO®, the first approved ustekinumab biosimilar to STELARA® in Europe, is indicated for the treatment of Crohn’s disease, psoriasis and psoriatic arthritis.  As we previously reported, Alvotech and STADA announced that the European Commission issued a marketing authorization for AVT04 in January 2024, and Alvotech announced in February 2024 that it had reached settlement agreements with Johnson & Johnson, clearing the way for Alvotech to launch AVT04 in multiple regions, including in the European Economic Area.  Chief Executive Officer of Alvotech, Robert Wessman, said “[t]his launch symbolizes the robustness of our platform, the value of our partnership with STADA, and our collective focus on the importance of biosimilars.”

Alvotech’s ustekinumab biosimilar was approved by the FDA in April 2024, under the name SELARSDI (ustekinumab-aekn).  According to Alvotech, SELARSDI is expected to be marketed in the United States on or after February 21, 2025, following its settlement agreement with Johnson & Johnson.

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