Ustekinumab biosimilar approved for children 6 years and up with plaque psoriasis, psoriatic arthritis

Ustekinumab biosimilar approved for children 6 years and up with plaque psoriasis, psoriatic arthritis | Image Credit: © 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) to treat patients aged 6 years and older with moderate to severe plaque psoriasis (candidates for phototherapy or systemic therapy) and for those with active psoriatic arthritis.

Ustekinumab-auub is approved to treat indications that are currently approved for ustekinumab. 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 biological product is one that is “highly similar to, and has no clinically meaningful differences from, a biological product already approved by the FDA,” often times called the reference product.

Biological products are approved after they meet the FDA’s approval standards, meaning health care professionals and their patients can expect the same safety and efficacy from each product. Biosimilar products could cost less than the brand-name reference product.

“Biosimilar medications offer additional safe and effective treatment options that have the potential to increase access for people requiring treatment for inflammatory diseases,” said Nikolay Nikolov, MD, director, Office of Immunology and Inflammation, FDA’s Center for Drug Evaluation and Research. “[This] approval could have a meaningful impact for patients managing their disease.”

According to the FDA, the approval of ustekinumab-auub biosimilar was based on evidence that demonstrated a highly similar profile to ustekinumab, and there are no clinically meaningful differences between the products.

Based on evidence, the biosimilar met legal requirements to be interchangeable with ustekinumab on the pharmacy level.

The most serious known side effect of ustekinumab-auub is infection, while the most common adverse reactions with ustekinumab products are nasopharyngitis, headache, upper respiratory tract infection, nausea, infection, pruritus, sinusitis, urinary tract infection, abdominal pain, influenza, fever, and diarrhea.

A warning is on the label for ustekinumab-auub to alert patients and health care professionals about an increased risk of serious infection that could lead to hospitalization. There is also a warning that “some malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome have been reported in patients who received Wezlana in clinical studies.”

Reference:

FDA approves interchangeable biosimilar for multiple inflammatory diseases. FDA. Press release. October 31, 2023. Accessed November 7, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases