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Erelzi Approval History

Erelzi (etanercept-szzs) is a tumor necrosis factor (TNF) blocker biosimilar to Enbrel indicated for the treatment of rheumatoid arthritis (RA), polyarticular juvenile idiopathic arthritis (JIA), psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis.

The FDA approval of Erelzi was based on analytical, nonclinical, and clinical data confirming that Erelzi is biosimilar to the reference product Enbrel.

Erelzi is administered by subcutaneous injection.

Erelzi comes with a Boxed Warning alerting health care professionals and patients of the increased risk of serious infections and malignancies. The most common reported side effects of Erelzi include infections and injection site reactions.

Development History and FDA Approval Process for Erelzi

DateArticle
Aug 31, 2016Approval FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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