Biocon Biologics Secures FDA Approval for YESINTEK, a Biosimilar to Stelara

FDA Approval:
Biocon Biologics Ltd. has received FDA approval for YESINTEK (ustekinumab-kfce), a biosimilar to Stelara (ustekinumab), for the treatment of Crohn's disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis14.

Commercialization Agreement:
Biocon Biologics entered into a settlement and licensing agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson to commercialize YESINTEK in the United States no later than February 22, 20251.

Biosimilar Market:
YESINTEK is the latest addition to the list of Stelara biosimilars approved by the FDA, following others like Wezlana (ustekinumab-auub) and Imuldosa (ustekinumab-srlf)235.

Market Impact:
The approval of YESINTEK and other Stelara biosimilars is expected to increase competition and potentially lower costs for patients with chronic inflammatory conditions23.

Regulatory Context:
The FDA's approval process for biosimilars ensures that these products meet rigorous standards for safety, effectiveness, and quality, similar to their reference products2.

Sources:

1. https://www.prnewswire.com/news-releases/us-fda-approves-biocon-biologics-yesintek-bmab-1200-biosimilar-to-jjs-stelara-ustekinumab-302319272.html

2. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases

3. https://www.ajmc.com/view/fda-approves-imuldosa-a-fifth-biosimilar-to-stelara

4. https://endpts.com/biocon-lands-fda-approval-for-another-stelara-biosimilar/

5. https://www.prnewswire.com/news-releases/fda-approves-imuldosa-ustekinumab-srlf-accord-biopharmas-biosimilar-to-stelara-ustekinumab-for-the-treatment-of-chronic-inflammatory-conditions-302274563.html