Wezlana

On October 31, 2023, the FDA granted approval to Wezlana (ustekinumab-auub), endorsing it as a biosimilar and interchangeable counterpart to the established Stelara (ustekinumab).

Indications

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.

Pediatric patients

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.

Prescribing information

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."

Biologics

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.

Biosimilars

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.

Importance

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.

Dosage

Medications administered through subcutaneous injection and intravenous infusion come in various dosage forms and strengths to accommodate different patient needs and conditions.

Subcutaneous Injection

• 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.

Intravenous Infusion

• Injection: Provided as 130 mg/26 mL (5 mg/mL) solution in a single-dose vial.

Side effects

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.

Warning

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.

Manufacturer

The approval of Wezlana has been granted to Amgen.

External links

• FDA announcement

Wezlana Resources
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