Loading Curie Briefs...
Getting the latest healthcare news for you
Getting the latest healthcare news for you
The FDA has approved two new prefilled autoinjector formulations for Yesintek (ustekinumab-kfce), a biosimilar of Stelara. Available in 45 mg and 90 mg doses, the autoinjectors are indicated for plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Manufacturer Biocon says the new delivery format supports more tailored treatment across different care settings.
The FDA has approved two new prefilled autoinjector formulations for Yesintek (ustekinumab-kfce, Biocon Limited), a biosimilar of the blockbuster immunology drug Stelara (ustekinumab). The newly approved formats — a 45 mg/0.5 mL and a 90 mg/mL single-dose prefilled autoinjector — expand the delivery options available for patients and providers.
Yesintek is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in adults and pediatric patients aged 6 and older, as well as moderate to severely active Crohn's disease and ulcerative colitis in adults. Biocon noted the new format "supports more tailored treatment approaches across different care settings and patient needs."
Originally approved in November 2024 as the sixth Stelara biosimilar, Yesintek entered the U.S. market in February 2025 following legal settlements with originator Janssen.
Key Takeaways:
Why it matters: Expanding delivery formats for biosimilars can improve patient adherence and broaden access to more affordable alternatives to high-cost biologics, supporting both clinical flexibility and cost savings across the healthcare system.
