On October 31, 2023, the FDA approved Amgen’s Wezlana™ (ustekinumab-auub) as the first biosimilar and interchangeable of Johnson & Johnson / Janssen’s Stelara® (ustekinumab). In May 2023, Amgen and Janssen settled their BPCIA lawsuit, with an agreement allowing Amgen to launch Wezlana no later than January 1, 2025.
In addition to Wezlana, there are at least two aBLAs pending at the FDA for Stelara biosimilars, including AVT04 filed by Alvotech and Teva (complete response letter received in October 2023), and CT-P43 filed by Celltrion (submitted in June 2023). If approved, AVT04 can enter the U.S. market no later than February 21, 2025, and CT-P43 can enter the U.S. market no later than March 7, 2025, based on settlement agreements.
The author would like to thank April Breyer Menon for her contribution to this article.