The FDA has approved ustekinumab-aauz (Otulfi), a biosimilar to Stelara by Johnson & Johnson, for treating conditions like Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. This marks the fourth biosimilar approval for ustekinumab. Otulfi, from Formycon and Fresenius Kabi, will launch in February 2025 due to a settlement agreement. Clinical trials have shown that Otulfi’s efficacy and safety are comparable to Stelara.
Fourth Ustekinumab Biosimilar, Otulfi, Approved in US (AJMC)
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