Alvotech announces FDA issued CRL for its BLA for AVT05

Alvotech (ALVO) announced that the U.S. Food and Drug Administration, FDA, has issued a complete response letter, CRL, for Alvotech’s Biologics License Application, BLA, for AVT05, in a prefilled syringe and autoinjector presentations, a biosimilar candidate to Simponi. The CRL noted that certain deficiencies, which were conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility that concluded in July 2025, must be satisfactorily resolved before this BLA for AVT05 can be approved. The FDA did not identify any other deficiencies with the application. The facility remains FDA approved to manufacture and continues supplying currently commercialized products.