Alvotech’s Japanese Ustekinumab Nod Is ‘First For Global Markets’
Stelara Biosimilar AVT04 To Be Commercialized By Partner Fuji Pharma
Following the formation of their partnership nearly five years ago, Alvotech and Fuji have together welcomed approval in Japan for Alvotech’s biosimilar to Stelara (ustekinumab).
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Alvotech and local partner Jamp Pharma have received the first Canadian approval for an ustekinumab biosimilar rival to Stelara in the form of Jamteki, with Health Canada’s marketing authorization following earlier nods for Alvotech’s AVT04 candidate in other geographies.
With its portfolio of biosimilars continuing to grow, Amgen has received the first approval in the US for a biosimilar to Stelara – weeks after Alvotech/Teva was hit with a complete response letter.
Alvotech has announced that, “as expected”, its US filing for its AVT04 ustekinumab candidate has resulted in a complete response letter from the FDA over manufacturing facility deficiencies, following similar knockbacks for its adalimumab biosimilar. However, the firm anticipates an inspection and a new goal date for the proposed Stelara rival long before its planned February 2025 launch date.