Alvotech falls as U.S. FDA declines to approve biosimilar to Humira

Alvotech SA

29/06/2023 12:42

** Shares of Luxembourg-based biotech Alvotech SA  ALVO.O 
fall 10.88% premarket to $6.55
    ** Co late on Wednesday said the U.S. Food and Drug
Administration has declined to approve co's second marketing
application for AVT02, a biosimilar to AbbVie Inc's  ABBV.N 
blockbuster arthritis drug Humira
    ** The regulator noted that certain deficiencies, which were
conveyed following the FDA's reinspection of co's Reykjavik
facility, must be satisfactorily resolved before the application
can be approved
    ** Co intends to resubmit its application for AVT02
    ** Due to the expected delay in the potential approval of
AVT02 in the US, co will explore options to raise additional
capital, in order to continue advancing pipeline development in
the near-term
    ** The health regulator previously rejected co's first
application in April
    ** Up to last close, stock down ~26% YTD

 (Reporting by Sriparna Roy in Bengaluru)
 ((Sriparna.Roy@thomsonreuters.com;))