{"id":108,"date":"2018-10-04T10:29:52","date_gmt":"2018-10-04T14:29:52","guid":{"rendered":"http:\/\/blogs.duanemorris.com\/lifescienceslaw\/?p=108"},"modified":"2018-10-04T10:29:52","modified_gmt":"2018-10-04T14:29:52","slug":"fda-estimates-for-formal-meetings-show-continued-growth-of-biosimilars-in-the-united-states","status":"publish","type":"post","link":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/10\/04\/fda-estimates-for-formal-meetings-show-continued-growth-of-biosimilars-in-the-united-states\/","title":{"rendered":"FDA Estimates for Formal Meetings Show Continued Growth of Biosimilars in the United States"},"content":{"rendered":"<p>Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for growth and health of the U.S. biosimilars industry. By that measure, the prospects for the U.S. biosimilars industry look bullish. This year, FDA\u00a0<a href=\"https:\/\/www.gpo.gov\/fdsys\/pkg\/FR-2018-09-11\/pdf\/2018-19674.pdf\" target=\"_blank\" rel=\"noopener\">revised<\/a>\u00a0its estimate for meeting requests upward by six respondents to Center for Drug Evaluation and Research (CDER) meeting requests, reflecting the industry\u2019s confidence in the growth of biosimilar market share in the United States.<\/p>\n<p>FDA\u2019s upward projection is consistent with independent estimates of potential biosimilar cost savings in the United States. In 2014, Rand Corporation estimated biosimilar cost savings over the next decade to be $44 billion. By 2017, Rand Corporation estimated biosimilar cost savings over the next decade to be $54 billion. The increase in estimated cost savings is premised on biosimilars gaining in market share of biologics prescriptions. These signs are all pointing toward increased growth of the U.S. biosimilars industry.<\/p>\n<p>Read the full text of this client <em>Alert<\/em>, including lists of what to have prepared for meeting requests and the actual meetings, on the <a href=\"https:\/\/www.duanemorris.com\/alerts\/fda_estimates_formal_meetings_regarding_development_biosimilar_continued_growth_1018.html\">Duane Morris LLP website<\/a>.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>Among the key aspects in the development of a biosimilar product for the U.S. market is taking advantage of formal meetings with the U.S. Food and Drug Administration to gain insight on moving a clinical development program for a proposed biosimilar product forward. Tracking meeting requests is also one way to measure the prospects for &hellip; <\/p>\n<p class=\"link-more\"><a href=\"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/2018\/10\/04\/fda-estimates-for-formal-meetings-show-continued-growth-of-biosimilars-in-the-united-states\/\" class=\"more-link\">Continue reading<span class=\"screen-reader-text\"> &#8220;FDA Estimates for Formal Meetings Show Continued Growth of Biosimilars in the United States&#8221;<\/span><\/a><\/p>\n","protected":false},"author":6,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[2],"tags":[191,29,301,300,299,298],"ppma_author":[521],"class_list":["post-108","post","type-post","status-publish","format-standard","hentry","category-general","tag-biosimilars","tag-fda","tag-industry-growth","tag-meeting-request","tag-neelaabh-shankar","tag-patrick-gallagher"],"authors":[{"term_id":521,"user_id":6,"is_guest":0,"slug":"duanemorris3","display_name":"Duane Morris","avatar_url":"https:\/\/secure.gravatar.com\/avatar\/843ff6e7a8fe5fc92109b47a45f34b6cf0ea499e6e788db23456c838b0ae6747?s=96&d=blank&r=g","0":null,"1":"","2":"","3":"","4":"","5":"","6":"","7":"","8":""}],"_links":{"self":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/108","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/comments?post=108"}],"version-history":[{"count":0,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/posts\/108\/revisions"}],"wp:attachment":[{"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/media?parent=108"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/categories?post=108"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/tags?post=108"},{"taxonomy":"author","embeddable":true,"href":"https:\/\/blogs.duanemorris.com\/lifescienceslaw\/wp-json\/wp\/v2\/ppma_author?post=108"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}