FDA Approves Ustekinumab Biosimilar Yesintek

The US Food and Drug Administration (FDA) has approved ustekinumab-kfce (Yesintek) as a biosimilar to ustekinumab (Stelara) for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis. 

This is the sixth ustekinumab biosimilar approved by the FDA. The biosimilar was developed by Biocon Biologics, a biosimilars company based in Karnataka, India.

Biocon will commercialize ustekinumab-kfce in the United States “no later than on February 22, 2025,” according to a company statement, as part of a settlement and licensing agreement with Johnson & Johnson, the makers of Stelara.