After multiple complete response letters from the US Food and Drug Administration relating to its AVT02 adalimumab biosimilar candidate, linked to manufacturing deficiencies at its Reykjavik facility, Alvotech has now revealed a similar fate for its AVT04 version of Stelara (ustekinumab).
Alvotech Receives CRL From FDA Over Ustekinumab Filing
Knockback For Stelara Biosimilar Comes After CRLs For Adalimumab Candidate
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.
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