TEVA

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)

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