Interchangeable Biosimilar Wezlana Gets FDA Approval

The Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub), an interchangeable biosimilar to Stelara (ustekinumab).

Wezlana is a human interleukin-12 and -23 antagonist. In adults, Wezlana is indicated for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn disease, and moderately to severely active ulcerative colitis. In children 6 years of age and older, Wezlana is approved for the treatment of moderate to severe plaque psoriasis in patients who are candidates for phototherapy or systemic therapy, and for active psoriatic arthritis.

According to the FDA, an interchangeable product is a biological agent that is approved based on data demonstrating that it is highly similar to an approved reference product and that there are no clinically meaningful differences between the products. The interchangeable product can be expected to produce the same clinical result as the reference product in any given patient. The biosimilar may be substituted for the reference product at the pharmacy similar to how generics are substituted for brand name drugs.

The approval of Wezlana was based on a comprehensive review of scientific evidence that showed the product was highly similar to Stelara with no clinically meaningful differences in safety, purity, or potency. Moreover, chemical and biological tests and biological assays showed that Wezlana and Stelara were similar in structural and functional features.

The biosimilar was also evaluated in a phase 3 study (ClinicalTrials.gov Identifier: NCT04607980) in adult patients with moderate to severe plaque psoriasis. Study participants were randomly assigned to receive Wezlana (n=281) or Stelara (n=282). The primary endpoint of the study was the percent improvement from baseline to week 12 in psoriasis area severity index (PASI). Findings showed no clinically meaningful differences between the groups; mean difference in percent improvement between Wezlana and Stelara was 0.14, which was within the prespecified margins. 

“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 of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research. “Today’s approval could have a meaningful impact for patients managing their disease.”