On July 24, 2024, Bio-Thera Solutions announced the FDA acceptance of its aBLA for BAT2206 (ustekinumab), a proposed biosimilar of Janssen and Johnson & Johnson’s Stelara® (ustekinumab), with a request for interchangeability. This aBLA is the seventh publicly announced aBLA filing for a Stelara® biosimilar. There are currently no pending patent disputes related to BAT2206.
To date, three Stelara® biosimilars have been approved by the FDA, Amgen’s Wezlana™ (ustekinumab-auub) (interchangeable), Alvotech and Teva’s Selarsdi™ (ustekinumab-aekn), and Samsung Bioepis and Sandoz’s Pyzchiva® (ustekinumab-ttwe) (interchangeable). Pending aBLAs include Celltrion’s CT-P43 (accepted by FDA in June 2023), Accord’s DMB-3115 (accepted by FDA in January 2024), and Biocon’s Bmab 1200 (FDA submission publicly announced February 2024).
Previously, Amgen settled Case No. 1:22-cv-01549 (D. Del.) with a launch date for Wezlana™ of no later than January 1, 2025; Biocon settled IPR2023-01444 with a launch date for Bmab 1200 in February 2025 (if FDA-approved); and Samsung Bioepis settled IPR2023-01103 with a launch date for Pyzchiva® of February 22, 2025.
Johnson & Johnson reported that Stelara® had U.S. sales of about $6.97B in 2023.
For more information on pending aBLAs and biosimilar-related patent disputes, please visit BiologicsHQ.com.
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The author would like to thank April Breyer Menon for her contributions to this article.
