MHLW (Japan) approves AVT 04 asa ustekinumab biosimilar
Alvotech announced that its commercialization partner in Japan, Fuji Pharma Co., Ltd. has received marketing approval for AVT 04 (ustekinumab), a biosimilar to Stelara , from the Japanese Ministry of Health, Labor and Welfare
Based on publicly available information, AVT 04 is the first biosimilar to Stelara to be approved for sale in global markets. Global sales of Stelara reached over $10 billion for the twelve months preceding June 30, 2023, according to the manufacturer’s public filings, making it one of the world’s highest grossing biologics.
AVT 04 was developed using an Sp2/0 host cell line and is manufactured by Alvotech using a continuous perfusion process. The Sp2/0 host cell line allows for more efficient sialylation of the molecule as compared to Chinese hamster ovary (CHO) cells and is the same type of host cell line used to produce Stelara. This is the first biosimilar approved under the commercial partnership between Alvotech and Fuji, which also includes six other biosimilar candidates to be developed and manufactured by Alvotech and commercialized by Fuji in Japan. The partnership agreement with Fuji was first announced in November 2018.
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