Alvotech Receives Complete Response Letter from the US FDA on the BLA for AVT04 (biosimilar, ustekinumab)
Shots:
- The US FDA has issued a complete response letter to Alvotech’s application for AVT04, a biosimilar candidate to Stelara citing certain deficiencies at Alvotech’s manufacturing facility in Reykjavik, Iceland during a site inspection in Mar 2023
- No other deficiencies were noted by the US FDA which stated that once these are resolved, it will approve the application. The company plans to resubmit the application for AVT04 to the FDA shortly which could trigger a 6mos. review period
- Alvotech and Teva reached a settlement and license agreement with J&J for AVT04 in the US in June 2023. AVT04 is expected to be available in the US in Feb 2025
Ref: Alvotech | Image: Alvotech
Related News:- Fuji Pharma Receives the MHLW Approval of AVT04 (biosimilar, ustekinumab) in Japan
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