On September 27, 2024, the FDA approved a fourth biosimilar of Janssen / Johnson & Johnson's Stelara® (ustekinumab): Fresenius Kabi and Formycon's Otulfi" (ustekinumab-aauz). Fresenius and Formycon announced Oltufi"'s approval in the E.U. on the same day. Oltufi"'s FDA-approval follows Amgen's Wezlana" (ustekinumab-auub), approved as an interchangeable biosimilar in October 2023, Alvotech and Teva's Selarsdi" (ustekinumab-aekn), approved in April 2024, and Samsung Bioepis and Sandoz's Pyzchiva® (ustekinumab-ttwe), approved as interchangeable in June 2024.
According to Fresenius Kabi's press release, under a settlement agreement with Johnson & Johnson, Otulfi" can be marketed in the U.S. starting no later than February 22, 2025. Under their settlement agreements, Wezlana" can enter the U.S. market no later than January 1, 2025, Selarsdi" no later than February 21, 2025, and Pyzchiva® no later than February 22, 2025.
There are numerous aBLAs for Stelara® biosimilars awaiting approval by the FDA, including Celltrion's CT-P43 (accepted in June 2023), Accord BioPharma's DMB-3115 (accepted in January 2024), Biocon's Bmab 1200 (announced in February 2024), and Bio-Thera's BAT2206 (ustekinumab) (accepted in July 2024).
There are no pending patent disputes related to Stelara® biosimilars.
Johnson & Johnson reported Stelara® U.S. sales of $6.97B in 2023.
The author would like to thank April Breyer Menon for her contributions to this article.
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