{"id":1641,"date":"2017-12-03T16:12:17","date_gmt":"2017-12-03T16:12:17","guid":{"rendered":"https:\/\/www.mybiosource.com\/learn\/?p=1641"},"modified":"2023-03-06T16:56:09","modified_gmt":"2023-03-06T16:56:09","slug":"us-fda-approves-mylan-biocons-ogivri-stomach-breast-cancer-treatment","status":"publish","type":"post","link":"https:\/\/www.mybiosource.com\/learn\/us-fda-approves-mylan-biocons-ogivri-stomach-breast-cancer-treatment\/","title":{"rendered":"US FDA Approves Mylan-Biocon’s Ogivri for stomach and breast cancer treatment"},"content":{"rendered":"

Table of Contents<\/strong><\/span><\/h2>\n

I. Introduction<\/strong>
\nII. FDA Commissioner\u2019s Statement<\/strong>
\nIII. Mylan and Biocon Collaboration<\/strong>
\n\u2022 Overview of the six biologic products developed
\n\u2022 Comparison of Ogivri to Roche\u2019s Herceptin
\nIV. Breast Cancer Statistics and Symptoms<\/strong>
\n\u2022 Number of breast cancer survivors in the US
\n\u2022 Common symptoms of breast cancer
\nV. Stomach Cancer Statistics<\/strong>
\n\u2022 Incidence of stomach cancer in the US
\n\u2022 Annual death rate for stomach cancer
\nVI. Conclusion<\/strong><\/p>\n

\n

US FDA<\/span> approved Ogivri co-developed by Mylan and Biocon for the treatment of breast and stomach cancer<\/span>. The drug is the first biosimilar<\/span> approved in the United States for treating cancer<\/span> of stomach and breast, and second biosimilar<\/span> overall approved for therapeutic use in oncology. A biosimilar<\/span> is no different than a biologic drug as it is comparable to the reference product in terms of safety, purity, and potency.<\/p>\n

According to FDA<\/span> Commissioner Scott Gottlieb<\/span>, \u201cThe FDA<\/span> continues to grow the number of biosimilar<\/span> approvals, helping to promote competition that can lower health care costs. This is especially important when it comes to diseases like cancer<\/span>, that have a high-cost burden for patients.\u201d He also added, \u201cWe\u2019re committed to taking new policy steps to advance our biosimilar<\/span> pathway<\/span> and promote more competition for biological drugs.\u201d<\/p>\n

In total, Mylan and Biocon have codeveloped six biologic products through collaboration. The latest product is comparable to Roche\u2019s biologic drug Herceptin<\/span>, a blockbuster drug used in treating stomach or breast cancer<\/span>. Biologic drugs are made from living cells and are understood to be hard to reverse engineer for commercial exploitation by competitors. Similar versions are called biosimilars instead of generics.<\/p>\n

There are 3.1 million breast cancer<\/span> survivors in the United States and chances of dying from breast cancer<\/span> is one in 37. The symptoms of breast cancer<\/span> include pain in the armpits, redness of the skin, rash around one or both nipples, a discharge from a nipple, change in size of the breast and peeling of the skin on the breast. Nearly 20,000 cases of stomach cancer<\/span> are diagnosed every year in the United States and approximately 10,000 people die of stomach cancer<\/span> annually.<\/p>\n","protected":false},"excerpt":{"rendered":"

Table of Contents I. Introduction II. FDA Commissioner\u2019s Statement III. Mylan and Biocon Collaboration \u2022 Overview of the six biologic products developed \u2022 Comparison of Ogivri to Roche\u2019s Herceptin IV. Breast Cancer Statistics and Symptoms \u2022 Number of breast cancer survivors in the US \u2022 Common symptoms of breast cancer V. Stomach Cancer Statistics \u2022 […]<\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_et_pb_use_builder":"","_et_pb_old_content":"","_et_gb_content_width":"","footnotes":""},"categories":[1],"tags":[],"class_list":["post-1641","post","type-post","status-publish","format-standard","hentry","category-uncategorized"],"_links":{"self":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/posts\/1641","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/users\/2"}],"replies":[{"embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/comments?post=1641"}],"version-history":[{"count":0,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/posts\/1641\/revisions"}],"wp:attachment":[{"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/media?parent=1641"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/categories?post=1641"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.mybiosource.com\/learn\/wp-json\/wp\/v2\/tags?post=1641"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}