{"id":196353,"date":"2024-12-16T16:50:06","date_gmt":"2024-12-16T16:50:06","guid":{"rendered":"https:\/\/news.talkwithrattan.com\/index.php\/2024\/12\/16\/aurobindo-pharma-arm-curateq-gets-positive-ema-opinion-for-biosimilar-zefylti-times-of-india\/"},"modified":"2024-12-16T16:50:06","modified_gmt":"2024-12-16T16:50:06","slug":"aurobindo-pharma-arm-curateq-gets-positive-ema-opinion-for-biosimilar-zefylti-times-of-india","status":"publish","type":"post","link":"https:\/\/news.talkwithrattan.com\/index.php\/2024\/12\/16\/aurobindo-pharma-arm-curateq-gets-positive-ema-opinion-for-biosimilar-zefylti-times-of-india\/","title":{"rendered":"Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti &#8211; Times of India"},"content":{"rendered":"<div style=\"text-align:center\"><img loading=\"lazy\" decoding=\"async\" width=\"400\" height=\"225\" src=\"https:\/\/i3.wp.com\/static.toiimg.com\/thumb\/msid-116375942,imgsize-201079,width-400,resizemode-4\/116375942.jpg?resize=400,225&amp;ssl=1\" class=\"attachment-post-thumbnail size-post-thumbnail wp-post-image\" alt=\"Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti &#8211; Times of India\" title=\"Aurobindo Pharma arm CuraTeQ gets positive EMA opinion for biosimilar Zefylti &#8211; Times of India\" \/><\/div><p> <br \/>\n<\/p>\n<div data-articlebody=\"1\">\n<div class=\"_s30J clearfix  \">\n<div class=\"MwN2O\">\n<div class=\"T22zO\">\n<section class=\"D3Wk1  clearfix id-r-component leadmedia undefined undefined  VtlfQ\" style=\"top:0px\">\n<div class=\"D3Wk1\" data-ua-type=\"1\" onclick=\"stpPgtnAndPrvntDefault(event)\">\n<div class=\"zPaFh\">\n<div class=\"wJnIp\"><\/div>\n<\/div>\n<\/div>\n<\/section>\n<\/div><\/div>\n<p>HYDERABAD: <!-- -->Aurobindo Pharma<!-- -->\u2019s wholly-owned subsidiary, <!-- -->CuraTeQ Biologics<!-- --> Private Limited, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European drug regulatory body, the <!-- -->European Medicines Agency<!-- --> (<!-- -->EMA<!-- -->), for its filgrastim biosimilar, Zefylti. The committee recommended granting marketing authorisation.<br \/>The Hyderabad-based company stated that Zefylti is its first biosimilar to receive a positive opinion from the EMA\u2019s CHMP after it received the GMP (good manufacturing practices) certificate from the EMA in November this year.<br \/>Zefylti, codenamed BP13, is intended for the treatment of neutropenia and the mobilisation of peripheral progenitor cells (PBPCs). It will be available in dosages of 30 MU per 0.5 mL and 48 MU per 0.5 mL.<br \/>\u201cTwo more products, our biosimilar versions of pegylated filgrastim (BP14) and trastuzumab (BP02), are currently under review with the EMA, and a biosimilar to bevacizumab (BP01) is under review with the UK-MHRA. We are confident and on track to bring these treatment options to patients next year,\u201d Aurobindo Pharma stated.<br \/>The Hyderabad-headquartered CuraTeQ is a global biopharmaceutical company focused on developing biosimilars for the treatment of various cancers and autoimmune diseases. It currently has a pipeline of 14 biosimilars for the oncology and immunology segments.<br \/>The company has end-to-end capabilities in producing a range of products, from bulk drug substances to fill-finish and packaged drug products.<\/div>\n<\/div>\n<p><script>\nvar _mfq = window._mfq || [];\n_mfq.push([\"setVariable\", \"toi_titan\", window.location.href]);\n!(function(f, b, e, v, n, t, s) {\n    function loadFBEvents(isFBCampaignActive) {\n      if (!isFBCampaignActive) {\n        return;\n      }\n      (function(f, b, e, v, n, t, s) {\n        if (f.fbq) return;\n        n = f.fbq = function() {\n          n.callMethod ? n.callMethod(...arguments) : n.queue.push(arguments);\n        };\n        if (!f._fbq) f._fbq = n;\n        n.push = n;\n        n.loaded = !0;\n        n.version = '2.0';\n        n.queue = [];\n        t = b.createElement(e);\n        t.async = !0;\n        t.defer = !0;\n        t.src = v;\n        s = b.getElementsByTagName(e)[0];\n        s.parentNode.insertBefore(t, s);\n      })(f, b, e, 'https:\/\/connect.facebook.net\/en_US\/fbevents.js', n, t, s);\n      fbq('init', '593671331875494');\n      fbq('track', 'PageView');\n    };\n    function loadGtagEvents(isGoogleCampaignActive) {\n      if (!isGoogleCampaignActive) {\n        return;\n      }\n      var id = document.getElementById('toi-plus-google-campaign');\n      if (id) {\n        return;\n      }\n      (function(f, b, e, v, n, t, s) {\n        t = b.createElement(e);\n        t.async = !0;\n        t.defer = !0;\n        t.src = v;\n        t.id = 'toi-plus-google-campaign';\n        s = b.getElementsByTagName(e)[0];\n        s.parentNode.insertBefore(t, s);\n      })(f, b, e, 'https:\/\/www.googletagmanager.com\/gtag\/js?id=AW-877820074', n, t, s);\n    };\n    function loadSurvicateJs(allowedSurvicateSections = []){\n      const section =  window.location.pathname.split('\/')[1]\n      const isHomePageAllowed = window.location.pathname === '\/' && allowedSurvicateSections.includes('homepage')\n      if(allowedSurvicateSections.includes(section) || isHomePageAllowed){\n        (function(w) {\n         function setAttributes() {\n                    var prime_user_status = window.isPrime ? 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The committee recommended granting marketing authorisation.The Hyderabad-based company stated that Zefylti is its first biosimilar to [&hellip;]<\/p>\n","protected":false},"author":2,"featured_media":196354,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"tdm_status":"","tdm_grid_status":"","fifu_image_url":"https:\/\/static.toiimg.com\/thumb\/msid-116375942,imgsize-201079,width-400,resizemode-4\/116375942.jpg","fifu_image_alt":"","footnotes":""},"categories":[604],"tags":[9695,20584,11335,86749,154080,289,154081,154079,86750,154078,273,406,20585,5840,272,154082],"amp_enabled":true,"_links":{"self":[{"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/posts\/196353"}],"collection":[{"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/comments?post=196353"}],"version-history":[{"count":1,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/posts\/196353\/revisions"}],"predecessor-version":[{"id":196355,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/posts\/196353\/revisions\/196355"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/media\/196354"}],"wp:attachment":[{"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/media?parent=196353"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/categories?post=196353"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/news.talkwithrattan.com\/index.php\/wp-json\/wp\/v2\/tags?post=196353"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}