{"id":1468,"date":"2017-12-04T13:45:10","date_gmt":"2017-12-04T11:45:10","guid":{"rendered":"https:\/\/dev.medizone.com\/?p=1468"},"modified":"2017-12-04T13:45:10","modified_gmt":"2017-12-04T11:45:10","slug":"fda-approves-mylan-and-biocons-ogivri-the-first-biosimilar-for-trastuzumab-in-the-usa","status":"publish","type":"post","link":"https:\/\/medizone.com\/en\/fda-approves-mylan-and-biocons-ogivri-the-first-biosimilar-for-trastuzumab-in-the-usa\/","title":{"rendered":"FDA approves Mylan and Biocon\u2019s Ogivri, the first biosimilar for trastuzumab in the USA"},"content":{"rendered":"<p>Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan\u2019s Ogivri\u2122 (trastuzumab-dkst), a biosimilar to Herceptin<strong>\u00a0<\/strong>(trastuzumab), co-developed with Biocon.<\/p>\n<p>Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).<\/p>\n<p>Ogivri is the first FDA-approved biosimilar to Herceptin and the first biosimilar from Mylan and Biocon\u2019s joint portfolio approved in the U.S. Mylan anticipates potentially being the first company to offer a biosimilar to Herceptin, as a result of Mylan\u2019s ability to secure global licenses for its trastuzumab product from Genentech and Roche earlier this year. This milestone secured a clear pathway to commercialize Mylan\u2019s biosimilar to Herceptin in various markets globally.<\/p>\n<p>Mylan and Biocon\u2019s biosimilar for Herceptin also is under review by regulatory authorities in\u00a0Australia,\u00a0Canada,\u00a0Europe and several additional markets. It is already approved in 19 countries around the world, including\u00a0India, thus providing increased access to this more affordable biologic for cancer patients.<\/p>\n<p>Source: Biosimilar news<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan\u2019s Ogivri\u2122 (trastuzumab-dkst), a biosimilar to Herceptin\u00a0(trastuzumab), co-developed with Biocon. Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric [&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":[16,20],"tags":[],"class_list":["post-1468","post","type-post","status-publish","format-standard","hentry","category-biosimilar-development","category-global-pharma-sourcing-2"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1468","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=1468"}],"version-history":[{"count":1,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1468\/revisions"}],"predecessor-version":[{"id":1469,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1468\/revisions\/1469"}],"wp:attachment":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/media?parent=1468"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/categories?post=1468"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/tags?post=1468"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}