Wezenla: A Biosimilar to Know
Wezenla (ustekinumab) is a biologic medication that is a biosimilar to Stelara (ustekinumab). Biosimilars are highly similar to reference products with no clinically meaningful differences, potentially offering a lower-cost option. Developed by Amgen, Wezenla is approved in both Europe and the United States (where it is known as Wezlana) for various inflammatory conditions in adults and pediatric patients.
What is a biosimilar?
A biosimilar differs from a generic drug. Generics are identical copies of small-molecule drugs, while biosimilars are highly similar, but not identical, biological products made from living organisms. Rigorous evaluation ensures biosimilars have no meaningful clinical differences from the original product. Some Wezenla formulations have an "interchangeable" designation from the FDA, allowing potential pharmacy-level substitution for the reference product based on state laws.
Mechanism of Action: How Wezenla Works
Wezenla's active substance, ustekinumab, is a monoclonal antibody that blocks interleukin-12 (IL-12) and interleukin-23 (IL-23). By targeting these messenger molecules, Wezenla disrupts the inflammatory process in autoimmune conditions. The binding of ustekinumab to the shared p40 subunit of IL-12 and IL-23 prevents activation of Th1 and Th17 pathways, reducing the inflammatory response in conditions like psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.
Indications and Administration
Wezenla is approved for several immune-mediated inflammatory diseases, with dosing and administration varying by condition.
Approved indications include:
- Plaque Psoriasis: Moderate to severe in adults and pediatric patients (6+).
- Psoriatic Arthritis (PsA): Active disease in adults and pediatric patients (6+), used alone or with methotrexate.
- Crohn's Disease: Moderately to severely active in adults (18+).
- Ulcerative Colitis: Moderately to severely active in adults (18+).
Administration methods:
- Subcutaneous (SC) Injection: For psoriasis, psoriatic arthritis, and maintenance in Crohn's/ulcerative colitis.
- Intravenous (IV) Infusion: Initial dose for adults with Crohn's or ulcerative colitis.
Potential Side Effects and Safety Considerations
Wezenla, like other medications, has potential side effects and requires healthcare provider monitoring.
Common Side Effects: Based on clinical trials, these include nasopharyngitis, upper respiratory tract infection, bronchitis, diarrhea, abdominal pain, nausea, vomiting, headache, fatigue, dizziness, and injection site reactions.
Serious Side Effects and Warnings: Wezenla is an immunosuppressant, increasing the risk of serious infections (including TB reactivation, for which patients are screened), certain cancers (especially non-melanoma skin cancer), and rare PRES (Posterior Reversible Encephalopathy Syndrome). Severe allergic reactions are also possible. Live vaccines should be avoided during treatment; complete age-appropriate immunizations beforehand.
Comparison: Wezenla vs. Stelara
For a detailed comparison of Wezenla (ustekinumab-auub) and Stelara (ustekinumab), including drug type, active ingredient, mechanism, indications, dosage/administration, clinical similarity, cost, and interchangeability, please refer to {Link: everyone.org https://everyone.org/explore/compare?id1=422&id2=582}.
Conclusion
Wezenla (ustekinumab) offers a valuable biosimilar alternative to Stelara for treating chronic inflammatory conditions. By blocking IL-12 and IL-23, it's an important option for patients with moderate to severe plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Due to its potency, patients must use Wezenla under careful medical supervision and be aware of potential side effects. Biosimilars like Wezenla can improve access to effective treatments for individuals managing these debilitating diseases. Patients seeking more details should consult their physician or pharmacist and review the medication guide. Additional product information in Europe can be found on the {Link: European Medicines Agency (EMA) https://www.ema.europa.eu/en/medicines/human/EPAR/wezenla} website.
