Sixth Stelara Biosimilar, Yesintek, Approved by FDA
Managed Healthcare Executive December 2, 2024
Yesintek is the latest Stelara biosimilar to gain FDA approval and it will be available in February 2025.
Biocon Biologics Ltd. announced today the FDA approval of Yesintek (ustekinumab-kfce), a sixth Stelara (ustekinumab) biosimilar, for the treatment of patients with inflammatory bowel disease, plaque psoriasis and psoriatic arthritis, according to the details of a news release. Yesintek will be available no later than Feb. 22, 2025 in the United States.
Yesintek is a monoclonal antibody, which are man-made proteins that are meant to stimulate the immune system, according to the National Cancer Institute.
Launch date is based on a licensing agreement between Biocon Biologics, Janssen Sciences Ireland and Johnson & Johnson. Although the patents for ustekinumab began expiring in 2023,...