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.
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The author would like to thank April Breyer Menon for her contributions to this article.
