FDA Approves Eticovo, Second Biosimilar Etanercept

April 29, 2019

Biosimilars Team

The Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro; Samsung Bioepis Co., Ltd.) for the treatment of multiple inflammatory diseases. Eticovo is a biosimilar to Enbrel (etanercept; Amgen Inc.), which was licensed in 1998. Both products are tumor necrosis factor blockers.

Eticovo is the second etanercept biosimilar. Erelzi (etanercept-szzs; Sandoz Inc.) was approved in August 2016. Neither Eticovo nor Erelzi is approved as an interchangeable product.

Eticovo is administered by subcutaneous injection. It is approved for all eligible indications:

  • Moderately to severely active rheumatoid arthritis, either as a standalone therapy or in combination with methotrexate;
  • Moderately to severely active polyarticular juvenile idiopathic arthritis in patients 2 years of age or older;
  • Active psoriatic arthritis, with or without methotrexate;
  • Active ankylosing spondylitis (an arthritis that affects the spine); and 
  • Chronic moderate to severe plaque psoriasis in patients 4 years of age or older who are candidates for systemic therapy or phototherapy.

Like Enbrel and Erelzi, Eticovo carries a Boxed Warning to alert health care professionals and patients about an increased risk of serious infections leading to hospitalization or death, including tuberculosis, bacterial sepsis, and invasive fungal infections (such as histoplasmosis). The Boxed Warning also notes that lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor blockers, including etanercept products. Eticovo must be dispensed with a patient Medication Guide that describes important information about its uses and risks.

The prescribing information for Eticovo is available here.