Eticovo, a Biosimilar to Enbrel, Gets FDA Approval

Samsung Bioepis has gained approval for their etanercept biosimilar in 38 countries in addition to the US.

The Food and Drug Administration (FDA) has approved Eticovo (etanercept-ykro; Samsung Bioepis), a biosimilar to Enbrel (etanercept; Amgen).

Eticovo is a tumor necrosis factor (TNF) blocker. Its biosimilarity has been demonstrated for the following indications:

  • Rheumatoid arthritis (RA): reducing signs/symptoms, inducing major clinical response, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active RA; can be initiated in combination with methotrexate (MTX) or used alone
  • Polyarticular juvenile idiopathic arthritis (JIA): reducing signs/symptoms of moderately to severely active polyarticular JIA in patients ≥2 years old.
  • Psoriatic arthritis (PsA): reducing signs/symptoms, inhibiting the progression of structural damage of active arthritis, and improving physical function in patients with PsA; can be used with or without MTX
  • Ankylosing spondylitis (AS): reducing signs/symptoms in patients with active AS.
  • Plaque psoriasis (PsO): treating patients ≥4 years old with chronic moderate to severe PsO who are candidates for systemic therapy or phototherapy.

Results from a 52-week phase 3 study, which randomized 596 patients with active RA to either Eticovo or Enbrel, showed comparable efficacy between the 2 groups (ACR20 response: Eticovo 80.8% vs Enbrel 81.5%) with a similar safety profile.

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Eticovo carries the same Boxed Warnings as the reference product related to an increased risk of serious infections as well as malignancies.

“The approval of Eticovo adds to our growing portfolio of anti-TNF medicines in the US, where we believe biosimilars can bring meaningful value to the country’s healthcare system,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis.

Eticovo will be supplied in single-dose prefilled syringes in 25mg/0.5mL and 50mg/mL strengths.

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This article originally appeared on MPR