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Erelzi FDA Approval History

FDA Approved: Yes (First approved August 30, 2016)
Brand name: Erelzi
Generic name: etanercept-szzs
Dosage form: Injection
Company: Sandoz Inc.
Treatment for: Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Psoriatic Arthritis, Ankylosing Spondylitis, Plaque Psoriasis

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 timeline for Erelzi

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

Further information

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