On December 18, 2024, Celltrion announced that the FDA has approved its ustekinumab biosimilar, STEQEYMA (ustekinumab-stba), referencing Jannsen’s STELARA. STEQEYMA is approved for subcutaneous injection or intravenous infusion in adult and pediatric patients for treatment of various psoriatic conditions, Crohn’s disease, and ulcerative colitis. STEQEYMA is the seventh ustekinumab biosimilar to be approved by the FDA. Ustekinumab is a monoclonal antibody that selectively inhibits human interleukin IL-12 and IL-23, cytokines that play a role in inflammatory immune responses.
According to Celltrion, STEQEYMA is expected to be marketed in the United States beginning in February 2025.