August 19, 2026
1 min read
Key takeaways:
- The FDA has approved two autoinjector doses of the biosimilar ustekinumab-kfce.
- The biosimilar is indicated for psoriasis, psoriatic arthritis, Crohn’s disease and ulcerative colitis.
The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce, according to a press release from the manufacturer.
Ustekinumab-kfce (Yesintek, Biocon Limited) will now be offered in a 45 mg/0.5 ml single-dose prefilled autoinjector and a 90 mg/ml single-dose prefilled autoinjector. The biosimilar is indicated for moderate to severe plaque psoriasis and active psoriatic arthritis in adult and pediatric patients 6 years and older, as well as moderate to severely active Crohn’s disease and ulcerative colitis in adults.
The FDA has approved a pair of prefilled autoinjector formulations for the Stelara biosimilar ustekinumab-kfce.
“This new delivery format supports more tailored treatment approaches across different care settings and patient needs,” read the statement from Biocon.
The FDA initially approved Yesintek on Nov. 29, 2024, as the sixth biosimilar for Stelara (ustekinumab, Janssen). It later made its market debut in the United States in February 2025, following legal settlements between Janssen and the various manufacturers of Stelara biosimilars, including Biocon.
“This supplemental approval enhances Biocon’s comprehensive portfolio of immunology products in the United States and reaffirms the company’s commitment to improving access to affordable medicines for patients around the world,” read the Biocon statement.
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