> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Fresenius/Formycon Stelara Biosimilar Approved
- URL: https://www.fdaweb.com/fresenius-formycon-stelara-biosimilar-approved/
- Published: 2024-10-01T12:00:00.000Z
- Updated: 2026-09-14T14:42:51.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5157899

FDA has approved Fresenius Kabi and Formycon’s biosimilar Otulfi (ustekinumab-aauz), a copy of Johnson & Johnson’s referenced Stelara, for treating Crohn’s disease, ulcerative colitis, moderate to severe plaque psoriasis and active psoriatic arthritis. The biosimilar was approved for both subcutaneous and intravenous formulations.

Ustekinumab is described as a monoclonal antibody that targets the cytokines interleukin-12 and interleukin-23 which play a role in inflammatory and immune responses. “The FDA approval of Otulfi (ustekinumab-aauz) is based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data,” the companies say. “Otulfi demonstrated comparable efficacy, safety, pharmacokinetics and immunogenicity to the reference drug Stelara in patients with moderate to severe psoriasis vulgaris (plaque psoriasis).”

Fresenius and Formycon say that under an earlier patent settlement with Johnson & Johnson the biosimilar will be launched 2/2025.