Etanercept-szzs has been approved by the U.S. Food and Drug Administration, a drug for multiple inflammatory diseases. It is a biosimilar to Etanercept. Etanercept was originally licensed in 1998.
Etanercept-szzs is administered via injection primarily for the treatment of:
Rheumatoid arthritis: It is useful for treating moderate to severe rheumatoid arthritis as a standalone therapy or in combination with methotrexate (MTX)
Polyarticular juvenile idiopathic arthritis: It is effective in treating moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older. It is also given in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone
An arthritis that affects the spine is known as active ankylosing arthritis
Plaque psoriasis: It is used for treating chronic to moderate plaque psoriasis in adult patients who are applicants for systemic therapy or phototherapy.
Primary care physician must thoroughly evaluate the prescribing information in the labeling instructions for detailed information about the approved uses. According to Janet Woodcock, M.D., Director of the FDA’s Center for Drug Evaluation and Research, the biosimilar pathway is an important mechanism to improve access to treatment for patients with rheumatic and autoimmune diseases. Members of FDA cautiously assess the structural and functional characteristics of these complex molecules. Health care physicians and patients should not get worried about any clinical change in safety and effectiveness from the reference product.”
Biological products are obtained from living organism and other sources like humans, animals, microorganisms or yeast. As per law, biosimilar is a product that shows similar effectiveness comparable to the already approved product. Etanercept-szzs has been approved by FDA, based on the results from structural and functional characterization, animal studies, human pharmacokinetics, pharmacodynamics, clinical immunogenicity data and other clinical safety and effectiveness data. These results that prove Etanercept-szzs is biosimilar to Etanercept. Patients with sepsis should never be prescribed Etanercept-szzs. Infections, neurologic events, congestive heart failure and hematologic events are the most serious side effects of Etanercept-szzs, while the most common side effects include infections and injection site reactions.
There is a warning on the box of Etanercept-szzs regarding the increased risk of serious infections further resulting in hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others. The box also contains information about the lymphoma and other malignancies which have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including Etanercept products. Medication guide containing information about the uses and risks associated with the drug must be present while dispensing drug.