On 2 December 2024, Biocon Biologics announced that the FDA has approved its Yesintek® (ustekinumab-kfce), biosimilar to J&J’s Stelara® (ustekinumab). Yesintek® joins five other previously FDA-approved Stelara® biosimilars: Formycon and Fresenius Kabi’s Otulfi® (September 2024), Alvotech and Teva’s Selarsdi™ (April 2024), Meiji Seika’s Imuldosa™ (October 2024), Samsung Bioepis’s Pyzchiva® (July 2024), and Amgen’s Wezlana® (October 2024).
Biocon can launch Yesintek® in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.