Alvotech up as FDA to decide on approval for Humira's biosimilar in April

Alvotech SA

22/12/2022 12:39

** Alvotech's shares  ALVO.O  up 12.04% at $9.3 before the
bell
    ** Drugmaker says U.S. FDA to decide on approval for its
anti-inflammatory drug candidate, AVT02, by April 13, 2023
    ** AVT02 is a biosimilar drug candidate of Abbvie's  ABBV.N 
rheumatoid arthritis drug Humira
    ** The regulator had previously declined to approve the drug
saying the company needed to fix certain issues at its facility
in Iceland  urn:newsml:reuters.com:*:nL4N30D2FG
    ** ALVO on Thursday said the regulator will make a fresh
decision following a reinspection of the company's facility,
expected in Q1 2023
    ** "We remain excited about the anticipated launch of AVT02
in the U.S. on July 1, 2023" said  Robert Wessman, founder and
executive chairman of Alvotech
    ** AVTO2 is already approved in Europe, Canada, UK
    ** Up to Wednesday's close, stock was down ~16% YTD 
 (Reporting by Khushi Mandowara in Bengaluru)
 ((Khushi.Mandowara@thomsonreuters.com;))