Alvotech and Teva Announce Acceptance of U.S. Biologics License Application for AVT04, a Proposed Biosimilar to Stelara® (ustekinumab)

January 6, 2023

https://www.globenewswire.com/news-release/2023/01/06/2584228/0/en/Alvotech-and-Teva-Announce-Acceptance-of-U-S-Biologics-License-Application-for-AVT04-a-Proposed-Biosimilar-to-Stelara-ustekinumab.html

REYKJAVIK, Iceland and PARSIPPANY, N.J., Jan. 06, 2023 (GLOBE NEWSWIRE) — Alvotech (NASDAQ:ALVO), a global biotech company specializing in the development and manufacture of biosimilar medicines for patients worldwide, and Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA), today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application (BLA) for AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab), which is prescribed to treat a variety of inflammatory conditions. The companies anticipate that the FDA’s review will be completed in the second half of 2023.

Read more at globenewswire.com

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