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Alvotech Announces Approval in Japan of AVT04 (ustekinumab), a Biosimilar to Janssen’s Stelara®

Sep 25, 2023

Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received marketing approval for AVT04 (ustekinumab), a biosimilar to Janssen’s Stelara®, from the Japanese Ministry of Health, Labor and Welfare.  Alvotech reported that, based on publicly available information this is the first ustekinumab biosimilar approved in Japan, and is also the first biosimilar approved under its agreement with Fuji which covers the commercialisation of seven biosimilars in total in Japan.

Alvotech and Fuji Pharma announced their exclusive agreement for the commercialisation of a Stelara® biosimilar in Japan in April 2019.