Samsung Bioepis Co., Ltd. today announced that the US Food and Drug Administration (FDA) has approved ETICOVO™ (etanercept-ykro), a biosimilar referencing ENBREL® (etanercept), across all eligible indications for the treatment of rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis. ETICOVO™ is Samsung Bioepis’ second anti-TNF biosimilar approved for marketing in the United States (US).
“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. “Through relentless process innovation and an uncompromising commitment to quality, we remain dedicated to advancing one of the industry’s strongest biosimilar pipelines.”
In addition to the US, Samsung Bioepis’ etanercept biosimilar has been approved for marketing in 38 countries, namely 28 European Union (EU) member states, the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein, as well as Switzerland, Canada, Brazil, Australia, New Zealand, Israel, and Korea.
In a 52-week Phase III clinical study, which randomized 596 patients with rheumatoid arthritis across 70 sites in 10 countries, ETICOVO™ demonstrated comparable safety and efficacy to the etanercept reference product (ENBREL®), as evidenced in ACR20 response rate of 80.8% in the ETICOVO™ arm versus 81.5% in the ENBREL® arm.ii This confirmed the 24-week study results of 78.1% in the ETICOVO™ arm versus 80.3% in the ENBREL® arm.iii
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