New FDA Approvals: FDA Grants Interchangeability to Otulfi 45 mg/0.5 mL Vial

Jun 12
Jun 12, 2025

April 30: The FDA granted interchangeability status to the Fresenius Group’s unit Fresenius Kabi USA, LLC and Formycon AG’s Otulfi (ustekinumab-aauz) for the 45 mg/0.5 mL single-dose vial for all of its indications: the treatment of adults and pediatric patients at least 6 years old with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, adults and pediatric patients at least 6 years old with active psoriatic arthritis, adults with moderately to severely active Crohn’s disease and adults with moderately to severely active ulcerative colitis. The agency first approved the biosimilar of Johnson & Johnson Innovative Medicine’s Stelara (ustekinumab) on Sept. 27, 2024, and gave it provisional interchangeability due to the unexpired period of exclusivity for Amgen Inc.’s Wezlana (ustekinumab-auub). Dosing for the interleukin-12/IL-23 antagonist varies based on indication. Fresenius Kabi did not respond to a request by AIS Health, a division of MMIT, for Otulfi pricing information.
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Angela Maas

Angela has an extensive background of editing, reporting and writing for trade and consumer publications. She has written Radar on Specialty Pharmacy since she joined AIS Health in 2005 and has broad knowledge of the various issues at play within the space. She also has written for Spotlight on Market Access since its 2017 launch. Before joining AIS Health, she was managing editor at Employee Benefit News and Employee Benefit News Canada and managing editor at Hem Aware (a hemophilia publication), Lupus Living and Momentum (a multiple sclerosis publication). She has a B.A. in English and an M.A. in British literature from Arizona State University.