Fresenius Kabi and Formycon Receive U.S. FDA Approval for Biosimilar Otulfi(TM)* (ustekinumab-aauz)
Fresenius Kabi announced today that the United States (U.S.) Food and Drug Administration (FDA) has approved OtulfiTM (ustekinumab-aauz), its ustekinumab biosimilar referencing Stelara® ** (ustekinumab). OtulfiTM is approved for the treatment of Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis.