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Eticovo FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 16, 2021.

FDA Approved: Yes (First approved April 25, 2019)
Brand name: Eticovo
Generic name: etanercept-ykro
Dosage form: Injection
Company: Samsung Bioepis Co., Ltd.

Eticovo (etanercept-ykro) 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 Eticovo was based on the results of a Phase III clinical study confirming that Eticovo demonstrated comparable safety and efficacy to the reference product Enbrel.
  • Eticovo is administered by subcutaneous injection.
  • Eticovo 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 Eticovo include infections and injection site reactions.

Development timeline for Eticovo

Apr 27, 2019Approval FDA Approves Eticovo (etanercept-ykro), a Biosimilar to Enbrel

Further information

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