Etanercept Biosimilar FDA Approved for PsA, AS

HealthDay News — A new biosimilar to treat rheumatoid arthritis, psoriatic arthritis, and other inflammatory diseases has been approved by the US Food and Drug Administration (FDA).

The drug Erelzi® (etanercept-szzs) is a biosimilar to Enbrel® (etanercept), which was approved by the FDA in 1998.

According to the FDA, Erelzi is given by injection to treat moderate to severe rheumatoid arthritis, either as a stand-alone therapy or in combination with methotrexate; moderate to severe polyarticular juvenile idiopathic arthritis in patients aged 2 and older; active psoriatic arthritis, including use in combination with methotrexate in psoriatic arthritis patients who do not respond adequately to methotrexate alone; active ankylosing spondylitis; and chronic moderate to severe plaque psoriasis in patients aged 18 and older who are candidates for systemic therapy or phototherapy.

The most common side effects of Erelzi are infection and injection site reactions. The most serious known side effects are infections, neurological events, congestive heart failure, and hematologic events. The drug should not be given to patients with sepsis, the FDA said. 

Erelzi carries a boxed warning about an increased risk of serious infections leading to hospitalization or death. The boxed warning also notes that lymphoma and other cancers, some fatal, have been reported in children and teens treated with tumor necrosis factor blockers, including etanercept products.


FDA approves Erelzi, a biosimilar to Enbrel [press release]. US Food and Drug Administration. Available at: Accessed September 1, 2016.

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