- within Criminal Law, Accounting and Audit and Law Practice Management topic(s)
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.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
[View Source]