Biosimilar News: FDA Approves Stelara Biosimilar Wezlana

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11/08/2023

The U.S. Food and Drug Administration (FDA) approved Wezlana (ustekinumab-auub) as a biosimilar to Stelara (ustekinumab) for psoriasis and multiple other inflammatory diseases. 

The FDA granted the approval of Wezlana to Amgen, Inc.

Wezlana, like Stelara, is approved to treat the following indications: 

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.

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.

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

The 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. 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 health care 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. Wezlana must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

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

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