FDA OKs Second Etanercept Biosimilar for Inflammatory Diseases

Megan Brooks


April 30, 2019

The US Food and Drug Administration (FDA) has approved a second biosimilar for etanercept (Enbrel, Amgen).

Etanercept-ykro (Eticovo, Samsung Bioepis Co) is approved across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis, and polyarticular juvenile idiopathic arthritis, the company announced.

The FDA approved the Enbrel biosimilar etanercept-szzs (Erelzi, Sandoz) for rheumatoid arthritis and other inflammatory diseases in 2016.

Eticovo was tested in a 52-week, phase 3 randomized study involving 596 patients with rheumatoid arthritis across 70 sites in 10 countries. The results demonstrated "comparable safety and efficacy" of Eticovo to the etanercept reference product, as evidenced by an ACR20 response rate of 80.8% with Eticovo and 81.5% with Enbrel, according to the company.

The 52-week results confirmed the 24-week results of ACR20, which were achieved by 78.1% of patients treated with Eticovo and by 80.3% of those treated with Enbrel, the company noted.

Eticovo has been approved in 38 countries and is Samsung Bioepis' second anti–tumor necrosis factor (TNF) biosimilar approved for marketing in the United States.

"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," Christopher Hansung Ko, president and CEO of Samsung Bioepis, said in a news release.

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