On December 1, 2024, Biocon announced that the FDA has approved YESINTEK™ (ustekinumab-kfce), a biosimilar to J&J’s STELARA®. YESINTEK is approved for the treatment of Crohn’s disease, Ulcerative Colitis, Plaque Psoriasis and Psoriatic Arthritis. According to the announcement, Biocon had entered into a settlement and licensing agreement with Janssen to commercialize YESINTEK in the United States no later than February 22, 2025, upon approval from the FDA.
YESINKTEK is the sixth ustekinumab biosimilar approved by the FDA, behind Amgen’s WEZLANA (ustekinumab-auub), approved in Oct. 2023; Alvotech’s SELARSDI (ustekinumab-aekn), approved in April 2024; Samsung Bioepis’s PYZCHIVA (ustekinumab-ttwe), approved in July 2024; Fresenius Kabi’s OTULFI (ustekinumab-aauz), approved in Sept. 2024; and Accord’s IMULDOSA (ustekinumab-srlf), approved in Oct. 2024.