Formycon Wins Stelara Interchangeability for Biosimilar

FDA has designated Formycon’s FYB202/Otulfi (ustekinumab-aauz) as an interchangeable biosimilar to Janssen’s reference biologic Stelara (ustekinumab) for treating psoriatic arthritis and plaque psoriasis, as well as Crohn’s disease, and ulcerative colitis. Ustekinumab is a human monoclonal antibody that selectively targets the p40 protein, a component common to both interleukin (IL)-12 and IL-23 cytokines, which play crucial roles in treating immune-mediated diseases like psoriasis and psoriatic arthritis, and inflammatory diseases like Crohn’s disease and ulcerative colitis, the company says.

FYB202/Otulfi was approved 9/2024 for treating the same conditions as Stelara. The approval and interchangeability designation are “based on a thorough evaluation of a comprehensive data package including analytical, pre-clinical, clinical and manufacturing data,” the company says.