Press Announcements > FDA approves Erelzi, a biosimilar to Enbrel

Press Announcements > FDA approves Erelzi, a biosimilar to Enbrel

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

The U.S. Food and Drug Administration today approved Erelzi, (etanercept-szzs) for multiple inflammatory diseases. Erelzi is a biosimilar to Enbrel (etanercept), which was originally licensed in 1998.

Erelzi is administered by injection for the treatment of:

• moderate to severe rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate (MTX);
• moderate to severe polyarticular juvenile idiopathic arthritis in patients ages two and older;
• active psoriatic arthritis, including use in combination with MTX in psoriatic arthritis patients who do not respond adequately to MTX alone;
• active ankylosing spondylitis (an arthritis that affects the spine); and 
• chronic moderate to severe plaque psoriasis in adult patients (18 years or older) who are candidates for systemic therapy or phototherapy.

Health care professionals should review the prescribing information in the labeling for detailed information about the approved uses.

Erelzi should not be administered to patients with sepsis.

The most serious known side effects with Erelzi are infections, neurologic events, congestive heart failure and hematologic events. The most common expected adverse reactions with Erelzi are infections and injection site reactions.

Erelzi contains a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, invasive fungal infections (such as histoplasmosis) and others. The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including etanercept products. The drug must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

For more information, please visit: Erelzi.