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Demystifying Biologics: What is the generic name for Skyrizi?

4 min read

Approved by the FDA in 2019 for the treatment of moderate-to-severe plaque psoriasis, many people wonder: What is the generic name for Skyrizi? The active ingredient for this widely-used biologic is risankizumab-rzaa.

Quick Summary

The generic name for the brand-name biologic Skyrizi is risankizumab-rzaa. It is a monoclonal antibody used to treat several inflammatory autoimmune conditions, including psoriasis, psoriatic arthritis, and Crohn's disease.

Key Points

  • Risankizumab-rzaa is the generic name for Skyrizi: The suffix “-rzaa” is an FDA identifier for this specific biologic product.

  • Skyrizi is a biologic medication: It's made from living cells and currently has no generic equivalent, only potential future biosimilars.

  • It works as a targeted IL-23 antagonist: Risankizumab blocks the IL-23 protein, a key contributor to chronic inflammation in autoimmune diseases.

  • Approved for multiple inflammatory conditions: Skyrizi treats plaque psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis.

  • Administration varies by condition: It's given by subcutaneous injection for psoriasis and psoriatic arthritis, and starts with IV infusions before switching to subcutaneous injections for Crohn's and ulcerative colitis.

  • Requires monitoring for infection and liver health: As an immunosuppressant, Skyrizi increases infection risk. TB screening and liver function monitoring are necessary.

  • Efficacy is strong in many patients: Clinical trials show significant effectiveness, particularly for psoriasis, with some studies indicating superior results over other biologics.

In This Article

The Generic Name for Skyrizi: Risankizumab-rzaa

For any brand-name medication, understanding its generic counterpart is crucial for transparency and comprehension of its active ingredients. In the case of Skyrizi, the generic name is risankizumab-rzaa. The suffix “-rzaa” is a unique identifier assigned by the FDA to a specific biologic product, distinguishing it from potential future biosimilars.

Biologics are complex molecules derived from living organisms, unlike traditional small-molecule drugs. This means biosimilars, if developed for risankizumab-rzaa, would be highly similar but not identical copies. Currently, risankizumab-rzaa is exclusively marketed under the brand name Skyrizi.

How Risankizumab Works: A Targeted Approach

Risankizumab is an interleukin-23 (IL-23) antagonist, a class of medications that target a key driver of inflammation in several autoimmune diseases.

What is an IL-23 Antagonist?

Interleukin-23 (IL-23) is a protein that significantly contributes to the inflammatory response, particularly in conditions like psoriasis and Crohn's disease where its overproduction is linked to chronic inflammation.

Risankizumab is a monoclonal antibody that specifically binds to the p19 subunit of the IL-23 protein. By blocking this subunit, it prevents IL-23 from interacting with immune cells, thereby interrupting the inflammatory signaling pathway and reducing inflammation and disease symptoms. This targeted mechanism is different from broader immunosuppressants that affect the entire immune system.

Medical Conditions Treated by Risankizumab

Under the brand name Skyrizi, risankizumab is approved by the FDA for the treatment of several chronic inflammatory diseases that benefit from targeting the IL-23 pathway.

Here are the primary conditions treated with Skyrizi:

  • Moderate-to-Severe Plaque Psoriasis: For adults suitable for systemic therapy or phototherapy.
  • Active Psoriatic Arthritis: In adults, usable alone or with non-biologic disease-modifying antirheumatic drugs (DMARDs).
  • Moderate-to-Severe Crohn's Disease: In adults.
  • Moderate-to-Severe Ulcerative Colitis: In adults.

Administration and Dosing

The method and frequency of Skyrizi administration depend on the condition being treated. For psoriasis and psoriatic arthritis, it's a subcutaneous injection. For inflammatory bowel diseases (Crohn's and ulcerative colitis), treatment starts with intravenous infusions in a clinic, followed by at-home subcutaneous injections for maintenance. Patients are trained by a healthcare provider on proper self-injection technique.

Side Effects and Safety Profile

Risankizumab, like all potent medications, has potential side effects. Being an immunosuppressant, it can reduce the body's ability to fight infections. Serious side effects are uncommon. Before starting treatment, patients are typically screened for tuberculosis (TB) and evaluated for liver function.

Common side effects may include:

  • Upper respiratory infections
  • Headache
  • Fatigue
  • Injection site reactions
  • Fungal infections (tinea)

Serious side effects requiring medical attention include:

  • Serious allergic reactions: Symptoms like facial swelling, hives, or breathing difficulty.
  • Serious infections: Signs such as fever, chills, or a persistent cough.
  • Liver problems: Symptoms like unexplained rash, nausea, vomiting, abdominal pain, jaundice, or dark urine.

Live vaccines should be avoided while taking Skyrizi due to the increased risk of infection from the vaccine itself. Discuss any planned vaccinations with a doctor before starting treatment.

Comparison with Other Biologics

Skyrizi is among several biologic options for inflammatory conditions. Clinical trials have compared its effectiveness and safety with other drugs, including other IL-23 antagonists and those with different mechanisms. Below is a high-level comparison of Skyrizi with two other common biologics.

Feature Skyrizi (risankizumab) Stelara (ustekinumab) Cosentyx (secukinumab)
Mechanism of Action IL-23 antagonist (blocks p19) IL-12 and IL-23 antagonist (blocks p40) IL-17A antagonist
Conditions Treated Psoriasis, Psoriatic Arthritis, Crohn's, Ulcerative Colitis Psoriasis, Psoriatic Arthritis, Crohn's, Ulcerative Colitis Psoriasis, Psoriatic Arthritis, Ankylosing Spondylitis, Non-radiographic axial spondyloarthritis
Administration (Psoriasis) Subcutaneous injection every 12 weeks (after initial doses) Subcutaneous injection every 12 weeks (after initial doses) Subcutaneous injection more frequently (e.g., weekly initially)
Efficacy in Psoriasis Demonstrated superior skin clearance compared to Stelara and Secukinumab in certain studies Effective, but comparative trials show less efficacy than Skyrizi for skin clearance in some studies Effective, but comparative trials show less efficacy than Skyrizi in some studies, particularly in specific subgroups
Manufacturer AbbVie Janssen Biotech Novartis

Individual responses to biologics can vary, and a healthcare provider will recommend the best treatment based on a patient's specific condition, history, and treatment response. Comparative clinical trials help inform these decisions, with some studies indicating a more favorable benefit/risk profile for risankizumab over certain competitors in specific indications.

Conclusion

To answer the question what is the generic name for Skyrizi?, it is risankizumab-rzaa. This selective IL-23 antagonist is a significant treatment for various inflammatory and autoimmune conditions, such as psoriasis, psoriatic arthritis, Crohn's disease, and ulcerative colitis. Its targeted action against a key inflammatory protein provides a focused way to manage chronic inflammation. While currently only available under its brand name, knowing the generic name is helpful for understanding treatment options. The decision to use Skyrizi or any other biologic should always be made in consultation with a qualified healthcare provider who can assess the benefits and risks based on individual health needs.

More detailed information is available in the full prescribing information for risankizumab-rzaa and on authoritative health websites like MedlinePlus.

Frequently Asked Questions

Skyrizi is a biologic medication, specifically a monoclonal antibody that works as an interleukin-23 (IL-23) antagonist.

Risankizumab (Skyrizi) is FDA-approved for moderate-to-severe plaque psoriasis, active psoriatic arthritis, moderately-to-severely active Crohn's disease, and moderately-to-severely active ulcerative colitis in adults.

No, Skyrizi currently does not have a generic version. As a biologic, it can only have biosimilar versions, none of which are presently available for risankizumab-rzaa.

For plaque psoriasis and psoriatic arthritis, maintenance injections are every 12 weeks. For Crohn's and ulcerative colitis, maintenance injections are every 8 weeks following an initial IV induction phase.

Common side effects include upper respiratory infections, headache, fatigue, injection site reactions, and fungal skin infections.

Avoid 'live' vaccines while on Skyrizi due to immunosuppression. Discuss all vaccinations with your doctor before and during treatment.

Effectiveness varies by condition and specific comparison. Some studies indicate superior efficacy for conditions like psoriasis compared to other biologics, but treatment choice should be made with your doctor.

References

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Medical Disclaimer

This content is for informational purposes only and should not replace professional medical advice.