FDA gives Biocon Biologics approval for Stelara biosimilar

Biocon Biologics has received permission from the Food and Drug Administration for Yesintek (ustekinumab-kfce), which is a biosimilar to Stelara.

Yesintek, a monoclonal antibody, is approved for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. 

[Read more; Evernorth to offer Stelara biosimilar at $0 out of pocket for patients early next year]

Biocon Biologics had previously announced on Feb. 29, 2024, that the company had entered into a settlement and licensing agreement with Janssen Biotech, Janssen Sciences Ireland and Johnson & Johnson (collectively known as Janssen) to commercialize Yesintek in the United States no later than on Feb. 22, 2025, upon approval from the FDA.

[Read more: Fresenius Kabi, Formycon receive FDA nod for Stelara biosimilar]