FDA Approves Interchangeable Biosimilar for Psoriatic Arthritis, Other Inflammatory Conditions

On October 31, the FDA approved ustekinumab-auub as an interchangeable biosimilar with ustekinumab for multiple inflammatory diseases. Ustekinumab, which targets interleukin (IL)-12 and IL-23, was first approved by the FDA in 2009.

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

The FDA approved ustekinumab-auub for the treatment of adult patients with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy, those with active psoriatic arthritis, those who have moderately to severely active Crohn disease, or patients with moderately to severely active ulcerative colitis.

Ustekinumab-auub was also approved to treat pediatric patients 6 years of age and older with moderate-to-severe plaque psoriasis who are candidates for phototherapy or systemic therapy or those with active psoriatic arthritis.

The FDA based their approval on a review of scientific evidence demonstrating its similarity to ustekinumab, finding no clinically meaningful differences between the two products in terms of safety and effectiveness. The FDA press release noted that the scientific evidence “included comparisons of the products on an analytical level using an extensive battery of chemical and biological tests and biological assays that confirmed similarity” of the two products.

The most serious known adverse effect of ustekinumab is infection. Other common adverse effects with ustekinumab products include nasopharyngitis, upper respiratory tract infection, headache, fatigue, nausea, vomiting, injection site erythema, vulvovaginal candidiasis/mycotic infection, bronchitis, pruritus, urinary tract infection, sinusitis, abdominal pain, influenza, fever and diarrhea.

“Today’s approval exemplifies the FDA’s longstanding commitment to support a competitive marketplace for biological products,” Sarah Yim, MD, Director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research said in a press release. “This approval can empower patients by helping to increase access to safe, effective and high-quality medications at potentially lower cost.”

Reference
FDA approves interchangeable biosimilar for multiple inflammatory diseases. News release. US Food and Drug Administration; October 31, 2023. Accessed November 6, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases.