On August 18, 2026, Biocon Ltd. (“Biocon”) announced that its U.S. subsidiary has received supplemental U.S. FDA approval for YESINTEK® (ustekinumab-kfce) in a single-dose prefilled autoinjector, 45 mg/0.5 mL and 90 mg/mL. YESINTEK® was originally approved by the FDA on November 29, 2024, in 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe; 45 mg/0.5 mL solution in a single-dose vial; and 130 mg/26 mL solution in a single-dose vial.
YESINTEK®, biosimilar to Janssen Biotech’s STELARA® (ustekinumab), is indicated for the treatment of moderate to severe plaque psoriasis, active psoriatic arthritis in adult and pediatric patients 6 years of age and older, and moderate to severe Crohn’s disease and ulcerative colitis in adults. To date, the FDA has approved eight ustekinumab biosimilar products.