Alvotech, Teva Shares Rise After FDA Accepts BLA for AVT04
06 Januar 2023 - 8:21PM
Dow Jones News
By Chris Wack
Shares of Alvotech and Teva Pharmaceutical Industries Ltd. were
both up after the U.S. Food and Drug Administration has accepted
for review a Biologics License Application for AVT04, Alvotech's
proposed biosimilar to Stelara ustekinumab.
Stelara, developed by Johnson & Johnson's Janssen
Pharmaceuticals, is prescribed to treat a variety of inflammatory
conditions, such as Crohn's disease, ulcerative colitis, plaque
psoriasis and psoriatic arthritis.
Alvotech shares were up 6% to $10.68, and Teva Pharma shares
were up 6% to $10.55. The companies anticipate that the FDA's
review will be completed in second half of 2023.
In August 2020, Alvotech and Teva entered into a strategic
partnership for the exclusive commercialization in the U.S. of five
of Alvotech's biosimilar product candidates. In May 2022, Alvotech
said that a confirmatory clinical, safety and efficacy study for
AVT04 had met its primary endpoint, demonstrating therapeutic
equivalence between Alvotech's biosimilar candidate and the
reference product in patients with moderate to severe chronic
plaque-type psoriasis.
Also in May 2022, Alvotech reported positive top-line results
from a pharmacokinetic similarity study for AVT04.
Write to Chris Wack at chris.wack@wsj.com
(END) Dow Jones Newswires
January 06, 2023 14:06 ET (19:06 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
Von Mär 2024 bis Apr 2024
Teva Pharmaceutical Indu... (NYSE:TEVA)
Historical Stock Chart
Von Apr 2023 bis Apr 2024
