The FDA has denied a biologics license application from Alvotech for its biosimilar to ustekinumab, citing “certain deficiencies” at the company’s facility in Reykjavik, Iceland, according to the manufacturer.
The announcement follows a complete response letter to Alvotech from the FDA regarding AVT04, the company’s biosimilar candidate to ustekinumab (Stelara, Janssen). According to a statement from Alvotech, the letter noted “certain deficiencies” uncovered following the FDA’s inspection of the company’s Reykjavik facility that concluded in