Wezlana is sanctioned for use in adults suffering from:
- Moderate to severe plaque psoriasis suitable for phototherapy or systemic treatment;
- Active Psoriatic Arthritis;
- Moderately to severely active Crohn's Disease;
- Moderately to severely active Ulcerative Colitis.
Furthermore, pediatric patients aged 6 and above are approved to use it for:
- Moderate to severe plaque psoriasis fit for phototherapy or systemic treatment; and
- Active psoriatic arthritis.
Medical practitioners are advised to consult the prescribing information included in the product labeling for complete details on the authorized uses.
"Biosimilar medications introduce more safe and efficient treatment choices that could improve accessibility for individuals needing therapy for inflammatory conditions," stated Dr. Nikolay Nikolov, who heads the Office of Immunology and Inflammation at the FDA's Center for Drug Evaluation and Research. "The authorization of Wezlana today could significantly influence patient care in disease management."
Biological products are designed to treat serious illnesses and chronic health issues. A biosimilar is a biological product that closely mirrors an already FDA-approved biological product (the reference product), without any significant clinical differences. An interchangeable biosimilar meets additional standards and may be substituted for the reference product by a pharmacist, without needing the prescriber's approval, depending on state pharmacy laws—akin to the substitution of generic drugs for brand names.
The FDA assures that all biological products, including biosimilars and interchangeable biosimilars, are only sanctioned after satisfying stringent approval criteria, ensuring equivalent safety and effectiveness to the reference products. These alternatives may offer cost savings over brand-name drugs.
The FDA's nod for Wezlana follows a thorough evaluation of evidence demonstrating its high similarity to Stelara, confirming no clinical differences in safety, purity, and potency. This assessment encompassed analytical comparisons, comprehensive biochemical and biological tests, assays verifying structural and functional likeness, and data on pharmacokinetics, immunogenicity, clinical safety, and effectiveness. Moreover, Wezlana satisfied legal criteria for pharmacy-level interchangeability with Stelara.
- Injection: Available as 45 mg/0.5 mL or 90 mg/mL solution in a single-dose prefilled syringe.
- Injection: Offered as 45 mg/0.5 mL solution in a single-dose vial.
Parallel to Stelara, Wezlana's most severe known adverse effect is infection. Common side effects include Nasopharyngitis, upper respiratory infections, headaches, fatigue, and gastrointestinal symptoms, among others.
Wezlana's labeling, like Stelara’s, carries a warning about the risk of serious infections and hospitalizations, potential malignancies, hypersensitivity reactions, and Posterior Reversible Encephalopathy Syndrome reported in clinical studies. It is mandatory for Wezlana to be accompanied by a Medication Guide outlining critical use and risk information.
The approval of Wezlana has been granted to Amgen.
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Contributors: Prab R. Tumpati, MD