The U.S. Food and Drug Administration (USFDA) on Wednesday approved Wezlana (ustekinumab-auub) as a biosimilar to and interchangeable with Stelara (ustekinumab) for multiple inflammatory diseases. The FDA granted the approval of Wezlana to Amgen, Inc.
According to the US regulator, 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.
Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses, it recommended.
“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. “Today’s approval could have a meaningful impact for patients managing their disease.”
According to USFDA, an interchangeable biosimilar is a biosimilar that has been shown to meet other requirements under the law and may be substituted for the reference product without consulting the prescriber. “The substitution may occur at the pharmacy, subject to state pharmacy laws which vary by state, a practice commonly called “pharmacy-level substitution” — similar to how generic drugs are substituted for brand name drugs,” it stated.
“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.”
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,” it added.
