FDA Approves Interchangeable Biosimilar for Ustekinumab

The U.S. Food and Drug Administration on October 31 approved ustekinumab-auub (Wezlana) as a biosimilar to and interchangeable with ustekinumab (Stelara) for multiple inflammatory diseases, including moderately to severely active Crohn’s disease and ulcerative colitis in adult patients.

The biosimilar was also approved to treat moderate to severe plaque psoriasis and active psoriatic arthritis.

The approval of ustekinumab-auub is based on a comprehensive review of scientific evidence demonstrating it is highly similar to reference ustekinumab and that there are no clinically meaningful differences between the 2 products in terms of safety, purity and potency.

The most serious known side effect of ustekinumab-auub is infection, as is the case with the reference product. The most common adverse reactions with ustekinumab products are 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.

Manufacturer Amgen said the projected launch date for ustekinumab-auub is “no later than January 1, 2025.”

Reference:
FDA approves interchangeable biosimilar for multiple inflammatory diseases. Press release. US Food and Drug Administration. October 31, 2023. Accessed November 1, 2023. https://www.fda.gov/news-events/press-announcements/fda-approves-interchangeable-biosimilar-multiple-inflammatory-diseases?utm_medium=email&utm_source=govdelivery