The US Food and Drug Administration (FDA) has approved Yesintek (ustekinumab-kfce). This is the sixth approved biosimilar to the reference medicinal product Stelara (ustekinumab). The drug is developed for treating and managing immune-mediated diseases like plaque psoriasis, psoriatic arthritis (PsA), and inflammatory bowel disease (IBD). This is a new therapeutic option and is likely to be available for use in the 2nd half of 2025. The launch of this medicinal product will offer patients one more effective and safe alternative.
What is Yesintek?
Yesintek is designated as a biosimilar of Stelara. This therapeutic drug is extremely equal in effectiveness, safety, and quality. The medicine is developed by Biocon Biologics. This is an Indian company which is based in Karnataka. Biocon aims to provide affordable quality treatment for those suffering from autoimmune diseases. Like Stelara, this medicinal product is designed to work by targeting the immune system to lower the inflammation and other symptoms related to these autoimmune conditions.
Approved Indications for Yesintek:
Yesintek (ustekinumab-kfce) is approved to manage and treat some of the following conditions: Plaque Psoriasis Psoriatic Arthritis IBD or Inflammatory Bowel Disease
Clinical Trials:
After conducting a phase 3 clinical trial, the company Biocon Biologics presented data at the European Academy of Dermatology and Venereology (EADV) 2024 Congress. The study compared two biosimilars Yesintek with Stelara. The study enrolled a total of 384 adult patients with moderate to severe plaque psoriasis. As per the Psoriasis Area and Severity Index (PASI), equal improvements in both groups after 28 weeks. Safety, effectiveness, and immune responses were found to be equal to Stelara.
As per Dr. Uwe Gudat, chief medical officer at Biocon, “Yesintek successfully met all trial expectations, which offers an effective treatment option for eligible patients.”
Launch Timeline and Other Biosimilars:
Yesintek (ustekinumab-kfce) joins an elite and growing list of Stelara biosimilars, including: Wezlana (going to be launched in January 2025) Pyzchiva, Imuldosa, Selarsdi, and Otulfi (going to be launched in late 2025)
Why This Approval Matters?
With the launch of Yesintek (ustekinumab-kfce), affordable biosimilar treatments can be accessed for life-threatening autoimmune conditions. With the introduction of more treatment options like Yesintek, patients across the world can readily access hard-to-source therapies at lower costs. With the development of Yesintek, the company Biocon Biologics continues fulfilling its commitment to help improve global healthcare by developing new, life-saving medicines.
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