The fourth ustekinumab biosimilar to receive FDA approval is Otulfi™, which was developed by Formycon AG and will be marketed by its partner Fresenius Kabi. Originally designated FYB202, the biosimilar’s nonproprietary name is ustekinumab-aauz. It is Fresenius Kabi’s fourth biosimilar approval in the US.
The FDA approval was based on the totality of evidence, including a phase 3 trial of Otulfi versus Stelara® in patients with moderate-to-severe plaque psoriasis.
Fresenius Kabi signed a settlement with the reference drug maker, Johnson & Johnson, to allow launch of the product no later than February 22, 2025, which is virtually the same launch date scheduled for two other competitors (Selarsdi™ and Pyzchiva®). Amgen’s Wezlana® will launch on January 1.
Decisions by the FDA are also awaiting for ustekinumab biosimilars by Accord/Intas, Celltrion, and Biocon.
