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Alvotech Receives CRL From FDA for AVT04, Biosimilar to Janssen’s Stelara® (ustekinumab)

Oct 12, 2023

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facility in March 2023.  No other deficiencies were noted by the FDA.  Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly.  This will likely trigger a new BsUFA date for Alvotech’s ustekinumab.

In June 2023 Alvotech and Teva (the exclusive commercialization partner for AVT04 in the US), reached a settlement and license agreement with Johnson & Johnson that grants an entry date for AVT04 in the US no later than 21 February 2025.

On 25 September 2023 Alvotech received approval in Japan for AVT04.