Alvotech Receives CRL From FDA Over Ustekinumab Filing

Knockback For Stelara Biosimilar Comes After CRLs For Adalimumab Candidate

 
• By Dave Wallace

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.

Sign outside of FDA's headquarters in White Oak, MD
The FDA issued a complete response letter over the AVT04 candidate • Source: Alamy

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