Alvotech Receives CRL From FDA Over Ustekinumab Filing
Knockback For Stelara Biosimilar Comes After CRLs For Adalimumab Candidate
Executive Summary
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.