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Home » Alvotech Gets 4th FDA Complete Response Letter, This Time for Stelara Biosimilar
Alvotech Gets 4th FDA Complete Response Letter, This Time for Stelara Biosimilar
Alvotech announced Thursday that the FDA has issued a complete response letter (CRL) for the company’s BLA for AVT04, a biosimilar candidate to Stelara (ustekinumab), for deficiencies found during a March FDA inspection of its manufacturing facility.