Biosimilar Ustekinumab-Kfce Shows Equivalence to Stelara
Investigators report that the safety profile is also similar between both drugs.
A biosimilar ustekinumab-kfce (Yesintek) demonstrated equivalent efficacy, safety, immunogenicity, and pharmacokinetics to ustekinumab (Stelara) for patients with moderate to severe chronic plaque psoriasis, according to data being presented at the 2025 American Academy of Dermatology Annual Meeting in Orlando, Florida.1
For the primary efficacy end point, investigators found that the percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at 12 weeks was equivalent. | Image Credit: fusssergei | stock.adobe.com
“The positive results from this phase 3 study reaffirm the quality and therapeutic equivalence of Yesintek compared to reference product, ustekinumab. This milestone underscores our commitment to providing cost-effective, high-quality biosimilars to patients with chronic conditions like psoriasis, expanding access to critical treatments globally,” Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, said in a news release.1
For the primary efficacy end point, investigators found that the percentage change from baseline in Psoriasis Area and Severity Index (PASI) score at 12 weeks was equivalent between both treatments. The mean difference was 0.68%, according to the study results. Furthermore, the safety profile was similar for both drugs throughout the study. As for pharmacokinetics and immunogenicity, the biosimilar was found to be similar to the reference product with no significant differences in either efficacy or safety. The study also assessed switching at 16 weeks, showing continued efficacy and safety through 52 weeks.1
“The results from this study show convincingly once more that in vitro analytical comparability translates well into in vivo clinical performance. The study reinforces the confidence we can have in the biosimilar regulatory pathways and the principles they are built on,” Uwe Gudat, MD, chief medical officer of Biocon Biologics, said in the news release.1 “Specifically, for Yesintek, the study shows that it offers an effective, safe, and comparable alternative to reference ustekinumab in the treatment of moderate to severe chronic plaque psoriasis and, by extension, the other indications for which ustekinumab is indicated.”
In previous studies, approximately 89% of patients that were re-randomized to ustekinumab achieved PASI 75 scores compared to 63% for the placebo. The median time to loss of PASI 75 was approximately 16 weeks, according to the clinical trial information. For psoriasis, the most common adverse reactions included nasopharyngitis, upper respiratory tract infection, headache, and fatigue.4
In December 2024, the biosimilar was approved to treat Chron disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis, in reference to ustekinumab. In February 2025, the company launched ustekinumab-kfce, which became the first biosimilar to ustekinumab in the US. The drug was available in all the same formulations provided by Stelart, including 45 mg/0.5 mL and 90 mg/mL prefilled syringes and 45 mg/0.5 mL and 130 mg/26 mL vials.2,3
“The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available,” Laura Wingate, chief education, support, and advocacy officer of the Crohn’s & Colitis Foundation, said in a news release.3
