{"id":16971,"date":"2020-03-31T18:19:20","date_gmt":"2020-03-31T16:19:20","guid":{"rendered":"https:\/\/www.hollandbio.nl\/?p=16971"},"modified":"2020-03-31T18:19:20","modified_gmt":"2020-03-31T16:19:20","slug":"biosanapharmas-biosimilar-phase-i-study-successful","status":"publish","type":"post","link":"https:\/\/www.hollandbio.nl\/en\/nieuws\/biosanapharmas-biosimilar-phase-i-study-successful\/","title":{"rendered":"BiosanaPharma\u2019s biosimilar phase I study successful"},"content":{"rendered":"\n<p class=\"wp-block-paragraph\">BiosanaPharma, an Australian\/Dutch biotech company, today announced the successful outcome of a comparative phase I clinical study in healthy volunteers of BP001, a biosimilar candidate to Xolair\u00ae (omalizumab). The study was conducted in Australia, with 84 healthy male volunteers. The results of the study show that bioavailability, safety, tolerability and immunogenicity of BP001 are comparable to those of Xolair\u00ae.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">BP001\nis produced by utilising BiosanaPharma\u2019s innovative \u20183C\nprocess\u2019, a fully continuous manufacturing process,\ncutting production costs by up to 90%. This makes BP001 the first <em>clinical <\/em>monoclonal\nantibody in the world to be produced with a fully continuous process, according\nto available market information.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\">This\nphase I study supports the further clinical development of BP001, where the\nnext step will be a phase III study comparing BP001 to the originator in\npatients with allergic asthma. This study is planned to start early 2021.<\/p>\n\n\n\n<p class=\"wp-block-paragraph\"><strong>Ard Tijsterman, CEO of BiosanaPharma<\/strong>: \u201cWe are very proud that we now have successful phase I results for our first biosimilar product. This validates our use of fully-continuous manufacturing for biologics and allows us to move forward in our quest to deliver low cost mAb biosimilars.\u201d <\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>BiosanaPharma<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">BiosanaPharma\nis a biotechnology company with operations in Australia, The Netherlands and\nSingapore. The company is headed by a team of entrepreneurs on a mission to\nmake monoclonal antibody therapeutics more <strong>affordable and accessible<\/strong> for\npatients through smart, disruptive technology. The company aims to increase\naffordability by using its proprietary 3C process, and to improve accessibility\nwith its novel oral formulation and delivery technology for biologics via its\nsubsidiary BiOraliX.<\/p>\n\n\n\n<h2 class=\"wp-block-heading\"><strong>omalizumab<\/strong><\/h2>\n\n\n\n<p class=\"wp-block-paragraph\">BP001\nis a biosimilar candidate of omalizumab. Omalizumab is an antibody targeted\ntowards free IgE; it is used to improve the control of severe persistent asthma\nthat is caused by an allergy, and chronic (long-term) spontaneous urticaria\n(itchy rash) in patients with elevated IgE who do not respond to treatment with\nantihistamines. <\/p>\n\n\n\n<p class=\"wp-block-paragraph\">The\nonly currently-approved product containing omalizumab is Xolair\u00ae, marketed by\nNovartis and Roche since 2006. Annual sales of Xolair\u00ae are ~USD 3.2B&nbsp;\n(2019). Xolair\u00ae is delivered via subcutaneous injections.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>BiosanaPharma, an Australian\/Dutch biotech company, today announced the successful outcome of a comparative phase I clinical study in healthy volunteers of BP001, a biosimilar candidate to Xolair\u00ae (omalizumab). The study was conducted in Australia, with 84 healthy male volunteers. The results of the study show that bioavailability, safety, tolerability and immunogenicity of BP001 are comparable [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"footnotes":""},"categories":[39],"tags":[],"class_list":["post-16971","post","type-post","status-publish","format-standard","hentry","category-gezondheid"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v28.0 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>BiosanaPharma\u2019s biosimilar phase I study successful - hollandbio<\/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:\/\/www.hollandbio.nl\/en\/nieuws\/biosanapharmas-biosimilar-phase-i-study-successful\/\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"BiosanaPharma\u2019s biosimilar phase I study successful - hollandbio\" \/>\n<meta property=\"og:description\" content=\"BiosanaPharma, an Australian\/Dutch biotech company, today announced the successful outcome of a comparative phase I clinical study in healthy volunteers of BP001, a biosimilar candidate to Xolair\u00ae (omalizumab). 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