FDA Approves Ustekinumab-Aauz as Biosimlar for Stelara
Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.
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The FDA has approved ustekinumab-aauz (Otulfi; Fresenius Kabi) as a biosimilar referencing ustekinumab (Stelara; Johnson and Johnson), with indications including Crohn disease, ulcerative colitis, moderate to severe plaque psoriasis, and active psoriatic arthritis. Ustekinumab is a human monoclonal antibody targeting the cytokines interleukin (IL)-12 and IL-23, which play a rule in the inflammatory and immune responses.
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“The FDA approval of Otulfi, Fresenius Kabi’s fourth biosimilar product in the US market, is an important milestone on our pathway to consistently broadening our biopharma portfolio in the US and worldwide. In line with our Vision 2026 growth strategy, we are fully committed to becoming a significant player in the biopharma field and offering essential treatment options for patients globally,” Sang-Jin Pak, MD, president of biopharma and member of the Fresenius Kabi Management Board, said in a news release.
