The US FDA has approved ustekinumab-aauz, a biosimilar of Johnson & Johnson’s ustekinumab (Stelara). This is the fourth ustekinumab biosimilar approved in the US, indicated for plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis in patients 6 years and older. Produced by Fresenius Kabi and Formycon, ustekinumab-aauz comes in two formulations for subcutaneous injection and intravenous infusion. It is set to launch in the US by February 22, 2025. This is Fresenius Kabi’s fourth biosimilar granted US approval, following adalimumab-aacf, tocilizumab-aazg, and pegfilgrastim-fpgk.
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FDA Approves Ustekinumab Biosimilar Otulfi
