The US Food and Drug Administration (FDA) has rejected Alvotech’s biologics licence application (BLA) for AVT04, a candidate that is a biosimilar to Johnson & Johnson’s (J&J) Stelara (ustekinumab).
In a complete response letter, the regulator pointed out deficiencies at Alvotech’s manufacturing facility in Reykjavik, Iceland, identified during a site inspection in March 2023.
No other deficiencies in the application were noted by the FDA, which stated that once these are resolved, it will approve the application.
Alvotech intends to resubmit the application for AVT04 to the FDA shortly.
This would trigger another six-month review cycle. A new Biosimilar User Fee Act goal date will be provided.
Alvotech chairman and CEO Robert Wessman stated: “AVT04 has recently been approved in Japan, and marketing applications for AVT04 are currently awaiting approval in other major markets.
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“Based on our latest interactions with the FDA, we are currently expecting that the agency will reinspect our facility at the beginning of next year.
“We look forward to being able to bring AVT04 to US patients, pending a satisfactory inspection and BLA approval no later than in February 2025, in accordance with our licence entry date agreement.”
Alvotech and AVT04 commercialisation partner Teva Pharmaceuticals signed a settlement and licence agreement with J&J in June 2023.
AVT04 is expected to be available in the US in February 2025.
Alvotech also has commercial partners in Africa, China, Europe, Japan, the Middle East, South America and other Asian countries.