Biocon Biologics, a division of Biocon, announced the green light from the US Food and Drug Administration (FDA) for Yesintek (ustekinumab-kfce), a biosimilar comparable to Stelara (ustekinumab).
Yesintek, a monoclonal antibody, has been sanctioned for addressing conditions such as Crohn’s disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis.
The Bengaluru-headquartered Biocon Biologics previously informed the Stock Exchange on February 29, 2024, of their settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson, collectively termed as Janssen. This agreement allows for the commercialization of Yesintek in the USA no later than February 22, 2025, contingent upon FDA approval, relayed the company spokesperson.