FDA Approves YESINTEK to Treat Autoimmune Diseases

Biocon Biologics has received U.S. Food and Drug Administration (FDA) approval for YESINTEK, a monoclonal antibody for the treatment of autoimmune conditions, including Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. YESINTEK is a biosimilar to the reference product, Stelara (ustekinumab). 

YESINTEK works by targeting specific proteins that contribute to inflammation, offering a new treatment option for patients with these chronic autoimmune diseases. Approval is expected to provide an alternative for patients who require effective therapies for managing these conditions.

As part of a licensing agreement, Biocon Biologics has partnered with Janssen Biotech Inc., Janssen Sciences Ireland and Johnson & Johnson to commercialize YESINTEK in the U.S. market.