Ustekinumab biosimilar approved for children 6 years and older with plaque psoriasis, psoriatic arthritis | Image source: © Calin – © Calin – stock.adobe.com.
The FDA recently announced the approval of ustekinumab-auub (Wezlana; Amgen) as an interchangeable biosimilar to ustekinumab (Stelara; Johnson & Johnson) for the treatment of patients 6 years and older with moderate to severe plaque psoriasis (phototherapy or Candidates for systemic therapy) for those with active psoriatic arthritis.
Ustekinumab-auub is approved to treat the indications for which ustekinumab is currently approved. These indications also include adult patients with moderate to severe plaque psoriasis, active psoriatic arthritis, moderately to severely active Crohn’s disease, and moderately to severely active ulcerative colitis .
According to the FDA, a biologic is a biological product that is “highly similar to an FDA-approved biological product without clinically significant differences,” often referred to as a reference product.
Biologic products are approved after meeting the FDA’s approval standards, which means healthcare professionals and their patients can expect the same safety and effectiveness from every product. Biosimilar products may cost less than branded reference products.
“Biosimilars provide additional safe and effective treatment options with the potential to increase access to patients who need treatment for inflammatory diseases,” said Nikolay Nikolov, MD, director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “( This) approval could have a meaningful impact on patient control of the disease.”
The FDA said the approval of the ustekinumab-auub biosimilar was based on evidence that it was highly similar to ustekinumab and that there were no clinically meaningful differences between the products.
Based on the evidence, this biosimilar meets the legal requirements to be interchangeable with ustekinumab at the pharmacy level.
The most serious known side effect of ustekinumab-auub is infection, and the most common adverse reactions of ustekinumab products are nasopharyngitis, headache, upper respiratory tract infection, nausea, infection, itching, sinusitis, urinary tract infection, abdominal pain, influenza, fever, and diarrhea .
The label for ustekinumab-auub includes a warning alerting patients and health care professionals of the increased risk of serious infections that may result in hospitalization. There is also a warning that “some cases of malignancy, allergic reactions, and reversible posterior encephalopathy syndrome have been reported in patients treated with Wezlana during clinical studies.”
refer to:
The FDA approves interchangeable biosimilars for a variety of inflammatory diseases. U.S. Food and Drug Administration. Press release. October 31, 2023. Accessed November 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases