Biocon Announces Supplemental U.S. FDA Approval For Prefilled Autoinjector For YESINTEK

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.