Alvotech rises on regulatory update for Humira and Stelara biosimilars

Alvotech SA

19/01/2024 18:57

** Shares of drug developer Alvotech SA  ALVO.O  rise 14.3%
to $14 
    ** Co announces the conclusion of the re-inspection of its
Iceland facility by the U.S. FDA which started on Jan. 10
    ** Co received a form 483, a type of agency report
containing "observations" that FDA inspectors "deem to be
objectionable"  
    ** Co says it believes that the observation is readily
addressable, and it intends to respond as quickly as possible
     ** Believes it is in a position to receive approvals in the
U.S. for AVT02 and AVT04, by Feb. 24, and April. 16, their
respective action dates
        ** AVT02 is a biosimilar candidate to AbbVie's  ABBV.N 
arthritis treatment Humira, and AVT04 a biosimilar for Johnson &
Johnson's  JNJ.N  psoriasis treatment Stelara
    ** The FDA in Oct. 2023 rejected co's marketing application
for AVT04 based on the inspection at co's Iceland facility,
citing "certain deficiencies" 
    ** Stock mostly flat in the last 12 months 

 (Reporting by Sneha S K)
 ((Sneha.SK@thomsonreuters.com;))