{"id":47465,"date":"2022-08-19T05:01:38","date_gmt":"2022-08-19T03:01:38","guid":{"rendered":"https:\/\/pharma-trend.com\/en\/european-commission-approves-celltrion-healthcares-vegzelma-ct-p16-biosimilar-bevacizumab-for-the-treatment-of-multiple-types-of-cancer\/"},"modified":"2022-08-19T05:01:38","modified_gmt":"2022-08-19T03:01:38","slug":"european-commission-approves-celltrion-healthcares-vegzelma-ct-p16-biosimilar-bevacizumab-for-the-treatment-of-multiple-types-of-cancer","status":"publish","type":"post","link":"https:\/\/pharma-trend.com\/en\/european-commission-approves-celltrion-healthcares-vegzelma-ct-p16-biosimilar-bevacizumab-for-the-treatment-of-multiple-types-of-cancer\/","title":{"rendered":"European Commission Approves Celltrion Healthcare\u2019s Vegzelma\u2122 (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer"},"content":{"rendered":"<div>\n<ul class=\"bwlistdisc\">\n<li>\n<i>Vegzelma\u2122 offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical cancers a new, safe, and effective treatment option at an affordable price<\/i>\n<\/li>\n<li>\n<i>Approval is based on clinical trial data demonstrating Vegzelma\u2122 is highly similar to Avastin<\/i><sup>\u00ae1<\/sup><i> (bevacizumab)<\/i>\n<\/li>\n<li>\n<i>Vegzelma\u2122 is Celltrion\u2019s third oncology biosimilar approved by the European Commission<\/i>\n<\/li>\n<\/ul>\n<p>INCHEON, South Korea&#8211;(BUSINESS WIRE)&#8211;Celltrion Healthcare announced today that the European Commission (EC) has approved Vegzelma\u2122 (CT-P16), a biosimilar bevacizumab referencing EU-approved Avastin<sup>\u00ae<\/sup>, for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and\/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.\n<\/p>\n<p><a href=\"https:\/\/mms.businesswire.com\/media\/20220817005324\/en\/1546637\/4\/CI_Business_Wire.jpg\"><img decoding=\"async\" src=\"https:\/\/mms.businesswire.com\/media\/20220817005324\/en\/1546637\/21\/CI_Business_Wire.jpg\"><\/a><\/p>\n<p>\n\u201c<!-- no quote -->The European Commission\u2019s approval of Vegzelma\u2122 will increase access to treatment for patients living with certain types of cancer at an affordable price,\u201d said Kevin Byoung Seo Choi, Senior Vice President and Head of Marketing Division at Celltrion Healthcare. \u201c<!-- no quote -->With proven similarities in efficacy and safety compared to the reference product Avastin<sup>\u00ae<\/sup>, Vegzelma\u2122 will be available to treat some of the most commonly diagnosed cancers, which collectively affect hundreds of thousands of European patients each year.\u201d\n<\/p>\n<p>\nThe EC approval of Vegzelma\u2122 follows the recommendation for marketing authorisation issued by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in June 2022.\n<\/p>\n<p>\nToday\u2019s approval is based on the totality of evidence, including the phase III pivotal trial in patients with metastatic or recurrent non-squamous non-small cell lung cancer. Results showed that, as a first-line treatment, Vegzelma\u2122 is highly similar to the reference product in terms of efficacy, safety and pharmacokinetics.<sup>2<\/sup>\n<\/p>\n<p>\nVegzelma\u2122 (CT-P16) is Celltrion\u2019s third oncology biosimilar approved for use in the EU, following the approval of Truxima<sup>\u00ae<\/sup> (biosimilar rituximab) and Herzuma<sup>\u00ae<\/sup> (biosimilar trastuzumab). Vegzelma\u2122 was also filed for regulatory approval with the U.S. Food and Drug Administration (FDA) in September 2021. Approval is expected during the third quarter of 2022.\n<\/p>\n<p class=\"bwalignc\">\n&#8211; <b>ENDS &#8211;<\/b>\n<\/p>\n<p>\n<b>Notes to Editors:<\/b>\n<\/p>\n<p>\n<b>About Celltrion Healthcare<\/b>\n<\/p>\n<p>\nCelltrion Healthcare is committed to delivering innovative and affordable medications to promote patients\u2019 access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 110 different countries. For more information, please visit: <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.celltrionhealthcare.com&amp;esheet=52816513&amp;newsitemid=20220817005324&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.celltrionhealthcare.com&amp;index=1&amp;md5=637409167b65dbe6066dc3a27317ec43\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.celltrionhealthcare.com<\/a>\n<\/p>\n<p>\n<b>About Vegzelma\u2122 (CT-P16, biosimilar bevacizumab)<\/b>\n<\/p>\n<p>\nVegzelma\u2122<b> <\/b>is an anti-cancer monoclonal antibody treatment biosimilar to Avastin<sup>\u00ae <\/sup>(bevacizumab). Vegzelma\u2122<b> <\/b>is a recombinant humanised monoclonal antibody which binds to VEGF, the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors Flt-1 (VEGFR-1), and kinase insert domain receptor (KDR) (VEGFR-2), on the surface of endothelial cells. Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.<sup>3<\/sup> In the EU, Vegzelma\u2122 is<b> <\/b>indicated for the treatment of patients with metastatic colorectal cancer, non-small cell lung cancer, metastatic renal cell carcinoma, ovarian cancer, advanced cervical cancer and metastatic breast cancer.\n<\/p>\n<p>\n<b>References<\/b>\n<\/p>\n<p>\n<sup>1<\/sup> Avastin is a registered trademark of Genentech Inc.\n<\/p>\n<p>\n<sup>2<\/sup> Ohe Y et al., Randomized Phase III Study Comparing the Efficacy and Safety of CT-P16, a New Biosimilar, to Reference Bevacizumab (Avastin) In Patients With Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC). Proceedings: American Association for Cancer Research (AACR) Annual Meeting 2022; April 8-13, 2022 New Orleans, Louisiana.\n<\/p>\n<p>\n<sup>3<\/sup> European Medicines Agency Summary of Product Characteristics (SmPC), Avastin. Available at <a target=\"_blank\" href=\"https:\/\/cts.businesswire.com\/ct\/CT?id=smartlink&amp;url=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Favastin-epar-product-information_en.pdf&amp;esheet=52816513&amp;newsitemid=20220817005324&amp;lan=en-US&amp;anchor=https%3A%2F%2Fwww.ema.europa.eu%2Fen%2Fdocuments%2Fproduct-information%2Favastin-epar-product-information_en.pdf&amp;index=2&amp;md5=2d3a1412bf9bb2291c5d48572e6f1035\" rel=\"nofollow noopener\" shape=\"rect\">https:\/\/www.ema.europa.eu\/en\/documents\/product-information\/avastin-epar-product-information_en.pdf<\/a> [Last accessed August 2022].\n<\/p>\n<p> <b>Contacts<\/b> <\/p>\n<p>\nHolly Barber<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;i&#x6c;&#x74;&#111;&#x3a;h&#x62;&#x61;&#114;&#x62;e&#x72;&#x40;&#104;&#x61;n&#x6f;&#x76;&#101;&#x72;c&#x6f;&#x6d;&#109;&#x73;&#46;&#x63;&#x6f;&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x68;&#x62;&#x61;&#x72;&#x62;&#x65;&#x72;&#x40;&#x68;&#x61;&#x6e;&#x6f;&#x76;&#x65;&#x72;&#x63;&#x6f;&#x6d;&#x6d;&#x73;&#x2e;&#x63;&#111;&#109;<\/a><br \/>+44 (0) 07759 301620<\/p>\n<p>Donna Curran<br \/>\n<br \/><a target=\"_blank\" href=\"&#109;&#x61;i&#108;&#x74;o&#x3a;&#x64;&#99;&#x75;r&#114;&#x61;n&#64;&#x68;&#97;&#x6e;o&#118;&#x65;r&#99;&#x6f;&#109;&#x6d;&#x73;&#46;&#x63;o&#109;\" rel=\"nofollow noopener\" shape=\"rect\">&#x64;&#x63;&#117;rr&#x61;&#x6e;&#64;&#104;a&#x6e;&#x6f;&#118;&#101;r&#x63;&#x6f;&#x6d;&#109;s&#46;&#x63;&#x6f;&#109;<\/a><br \/>+44 (0) 7984 550312\n<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>Vegzelma\u2122 offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical cancers a new, safe, and effective treatment option at an affordable price Approval is based on clinical trial data demonstrating Vegzelma\u2122 is highly similar to Avastin\u00ae1 (bevacizumab) Vegzelma\u2122 is Celltrion\u2019s third oncology biosimilar approved by the European Commission &#8230; <span class=\"more\"><a class=\"more-link\" href=\"https:\/\/pharma-trend.com\/en\/european-commission-approves-celltrion-healthcares-vegzelma-ct-p16-biosimilar-bevacizumab-for-the-treatment-of-multiple-types-of-cancer\/\">[Read more&#8230;]<\/a><\/span><\/p>\n","protected":false},"author":4,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[13],"tags":[],"class_list":{"0":"entry","1":"post","2":"publish","3":"author-business","4":"post-47465","6":"format-standard","7":"category-industry"},"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.3 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>European Commission Approves Celltrion Healthcare\u2019s Vegzelma\u2122 (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer - Pharma Trend<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/pharma-trend.com\/en\/european-commission-approves-celltrion-healthcares-vegzelma-ct-p16-biosimilar-bevacizumab-for-the-treatment-of-multiple-types-of-cancer\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"European Commission Approves Celltrion Healthcare\u2019s Vegzelma\u2122 (CT-P16, biosimilar bevacizumab) for the Treatment of Multiple Types of Cancer - Pharma Trend\" \/>\n<meta property=\"og:description\" content=\"Vegzelma\u2122 offers European patients living with certain types of breast, lung, renal, colon, rectum, ovarian and cervical cancers a new, safe, and effective treatment option at an affordable price Approval is based on clinical trial data demonstrating Vegzelma\u2122 is highly similar to Avastin\u00ae1 (bevacizumab) Vegzelma\u2122 is Celltrion\u2019s third oncology biosimilar approved by the European Commission ... 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