FDA Approves Wezlana as an Interchangeable Biosimilar to Stelara for Multiple Inflammatory Diseases

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The U.S. Food and Drug Administration (FDA) has granted approval to Wezlana (ustekinumab-auub) as an interchangeable biosimilar to Stelara (ustekinumab) for the treatment of various inflammatory diseases. Wezlana is now approved to address the following medical conditions in both adult and pediatric patients:

For Adult Patients:

1. Moderate to severe plaque psoriasis, especially for those suitable for phototherapy or systemic therapy.

2. Active psoriatic arthritis.

3. Moderately to severely active Crohn’s disease.

4. Moderately to severely active ulcerative colitis.

For Pediatric Patients (6 years of age and older):

1. Moderate to severe plaque psoriasis for those candidates for phototherapy or systemic therapy.

2. Active psoriatic arthritis.

Healthcare professionals are urged to refer to the prescribing information provided in the label for a comprehensive understanding of the approved uses.

According to Dr. Nikolay Nikolov, Director of the Office of Immunology and Inflammation in the FDA’s Center for Drug Evaluation and Research, biosimilar medications such as Wezlana offer additional safe and effective treatment options, potentially enhancing access for individuals requiring treatment for inflammatory diseases. The approval of Wezlana is expected to positively impact patients managing these conditions.

Biological products encompass treatments for a wide range of serious illnesses and chronic health conditions. Biosimilars are biological products that closely resemble an FDA-approved biological product (known as the reference product) and exhibit no clinically meaningful differences. An interchangeable biosimilar, on the other hand, meets additional legal requirements and may be substituted for the reference product without prescriber consultation. This substitution is typically carried out at the pharmacy, subject to state pharmacy laws, similar to generic drugs replacing brand-name medications.

It’s crucial to note that all biological products, including biosimilars and interchangeable biosimilars, undergo rigorous approval standards set by the FDA, ensuring that they deliver the same level of safety and effectiveness as the reference product. Additionally, these products may offer a more cost-effective alternative to brand-name medications.

Dr. Sarah Yim, Director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, emphasized that the FDA’s approval of Wezlana reflects its commitment to supporting a competitive marketplace for biological products. This approval can empower patients by increasing access to safe, effective, and high-quality medications at potentially lower costs.

The FDA’s approval of Wezlana is based on a comprehensive review of scientific evidence demonstrating its high similarity to Stelara. No clinically meaningful differences were found between the two products concerning safety, purity, and potency, which includes safety and effectiveness. The evidence supporting this conclusion involved extensive analytical comparisons of the two products, as well as clinical data, pharmacokinetic data, immunogenicity data, and other data related to safety and efficacy. Wezlana also met the legal requirements for interchangeability with Stelara at the pharmacy level.

It’s important to note that like Stelara, the most serious known side effect of Wezlana is infection. The most common adverse reactions associated with ustekinumab products include 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 includes warnings about the increased risk of serious infections leading to hospitalization, malignancies, hypersensitivity reactions, and cases of Posterior Reversible Encephalopathy Syndrome. Wezlana is to be dispensed with a patient Medication Guide that contains vital information about its uses and associated risks.

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

Source: FDA