LAKE ZURICH, Ill. — The U.S. Food and Drug Administration (FDA) has granted interchangeable biosimilar designation to Otulfi® (ustekinumab-aauz), developed by Fresenius Kabi and Formycon AG, marking a significant regulatory milestone for the therapy. Otulfi is now approved as an interchangeable biosimilar to Stelara® (ustekinumab), a biologic drug used to treat autoimmune conditions such as Crohn’s disease, ulcerative colitis, and plaque psoriasis.
The designation allows Otulfi to be substituted for Stelara at the pharmacy level without the need for prior approval from the prescribing physician, depending on individual state laws. Not all biosimilars receive this status, which is reserved for products that meet the FDA’s highest standards of similarity in terms of safety, efficacy, and immunogenicity.
“Fresenius Kabi is pleased to receive this interchangeable designation for Otulfi,” said Dr. Sang-Jin Pak, President of Biopharma and a member of the Fresenius Kabi Management Board. “This achievement supports our mission to improve access to high-quality, affordable therapies for patients and healthcare professionals.”
The designation comes under revised FDA guidance that allows biosimilar developers to seek interchangeability status using data from their existing Biologics License Applications (BLAs), streamlining the approval process. Previously, biosimilar sponsors were required to conduct additional switching studies to demonstrate that patients could alternate between the biosimilar and the reference product without any meaningful differences in outcomes.
With this designation, Otulfi becomes one of a select group of biosimilars that can be automatically substituted for its reference product, potentially expanding patient access and reducing healthcare costs.
