FDA Approves Wezlana, First Interchangeable Biosimilar to Stelara

The U.S. Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for adult patients with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; active psoriatic arthritis; moderately to severely active Crohn’s disease; and moderately to severely active ulcerative colitis. It is also approved for pediatric patients 6 years of age and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy and active psoriatic arthritis.

FDA’s approval of Wezlana is based on a comprehensive 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 (i.e., safety and effectiveness). This 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 in the structural and functional features of Wezlana and Stelara (including those known to impact safety and efficacy), and comparative human pharmacokinetic data, clinical immunogenicity data and other clinical safety and effectiveness data. The evidence also demonstrated that Wezlana met the other legal requirements to be interchangeable with Stelara at the pharmacy level.

Like Stelara, the most serious known side effect of Wezlana is infection. 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.

The labeling for Wezlana, like Stelara, contains a warning to alert healthcare professionals and patients about an increased risk of serious infections leading 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.