Erelzi Approval History
- FDA approved: Yes (First approved August 30th, 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 History and FDA Approval Process for Erelzi
|Aug 31, 2016||FDA Approves Erelzi (etanercept-szzs), a Biosimilar to Enbrel|
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