{"id":1175,"date":"2015-11-23T12:18:33","date_gmt":"2015-11-23T10:18:33","guid":{"rendered":"https:\/\/dev.medizone.com\/?p=1175"},"modified":"2017-09-06T11:28:51","modified_gmt":"2017-09-06T09:28:51","slug":"samsung-bioepis-wins-ema-nod-for-the-first-etanercept-biosimilar-in-the-european-union","status":"publish","type":"post","link":"https:\/\/medizone.com\/en\/samsung-bioepis-wins-ema-nod-for-the-first-etanercept-biosimilar-in-the-european-union\/","title":{"rendered":"Samsung Bioepis wins EMA nod for the first etanercept biosimilar in the European Union"},"content":{"rendered":"<p>Samsung Bioepis Co., Ltd. announced that the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali \u2013 a biosimilar version of Enbrel<sup>\u00ae<\/sup>\u00a0(etanercept).<\/p>\n<p>The drug, previously known as SB4 \u2013 for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) and plaque psoriasis. This marks the first time the CHMP has adopted a positive opinion on an etanercept biosimilar.<\/p>\n<p>The CHMP\u2019s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Benepali<sup>\u00ae<\/sup>. If a marketing authorization is granted, Benepali will be the first etanercept biosimilar to be approved in the European Union (EU).<\/p>\n<p>\u201cWe are very pleased to have developed the first etanercept biosimilar to receive a positive CHMP opinion,\u201d said Christopher Hansung Ko, CEO of Samsung Bioepis. \u201cBy leveraging our strengths in product development and quality assurance, we will continue to focus on developing affordable, high-quality biologic treatment options for patients in Europe who need these life-enhancing medications.\u201d<\/p>\n<p>This positive CHMP opinion on Benepali was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Benepali to Enbrel. In the 52-week Phase 3 clinical study, which involved 596 patients randomized across 70 sites in 10 countries, Benepali demonstrated comparable safety and equivalent efficacy to Enbrel, as evidenced in ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm.<\/p>\n<p>Source: Biosimilar News<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Samsung Bioepis Co., Ltd. announced that the European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Benepali \u2013 a biosimilar version of Enbrel\u00ae\u00a0(etanercept). The drug, previously known as SB4 \u2013 for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis (ankylosing spondylitis and non-radiographic axial spondyloarthritis) [&hellip;]<\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":"","_links_to":"","_links_to_target":""},"categories":[16],"tags":[],"class_list":["post-1175","post","type-post","status-publish","format-standard","hentry","category-biosimilar-development"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1175","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/users\/4"}],"replies":[{"embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/comments?post=1175"}],"version-history":[{"count":1,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1175\/revisions"}],"predecessor-version":[{"id":1176,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1175\/revisions\/1176"}],"wp:attachment":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/media?parent=1175"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/categories?post=1175"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/tags?post=1175"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}