FDA approves Wezlana, a Stelara biosimilar

FDA has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases, including adults with certain types of moderate-to-severe plaque psoriasis, active psoriatic arthritis, and moderate-to-severe active ulcerative colitis, as well as children six years and older with certain types of moderate-to-severe plaque psoriasis and active psoriatic arthritis. 

“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, M.D., director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, in an agency news release. “Today’s approval could have a meaningful impact for patients managing their disease.”

The approval, which was granted to Amgen, was based on a review of scientific evidence “demonstrating it is highly similar to Stelara and that there are no clinically meaningful differences between the two products in terms of safety, purity and potency.”

Similar to Stelara, the most series side effect of Wezlana is infection, and the labeling indicates a warning to alert healthcare professionals and patients to this increased risk.