{"id":1522,"date":"2018-06-07T10:05:47","date_gmt":"2018-06-07T08:05:47","guid":{"rendered":"https:\/\/dev.medizone.com\/?p=1522"},"modified":"2018-06-07T10:05:47","modified_gmt":"2018-06-07T08:05:47","slug":"fda-approves-mylan-and-biocons-fulphila-the-first-biosimilar-to-neulasta","status":"publish","type":"post","link":"https:\/\/medizone.com\/en\/fda-approves-mylan-and-biocons-fulphila-the-first-biosimilar-to-neulasta\/","title":{"rendered":"FDA approves Mylan and Biocon\u2019s Fulphila, the first biosimilar to Neulasta"},"content":{"rendered":"<p>Mylan N.V. and Biocon Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved Mylan\u2019s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta<strong>\u00a0<\/strong>(pegfilgrastim), co-developed with Biocon.<\/p>\n<p>Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer.<\/p>\n<p>Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon\u2019s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be\u00a0available\u00a0at launch to further support patients and caregivers with treatment.<\/p>\n<p>Mylan has a portfolio of 20 biosimilar and insulin analog products\u00a0and deep experience with more than 60 marketing authorizations for biosimilar products worldwide.<\/p>\n<p>Mylan was the first company to receive FDA\u00a0approval\u00a0of Ogivri, a biosimilar to Herceptin<strong>\u00a0<\/strong>(trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world.<\/p>\n<p>Source: Mylan press release<\/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 Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta\u00a0(pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) [&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-1522","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\/1522","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=1522"}],"version-history":[{"count":1,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1522\/revisions"}],"predecessor-version":[{"id":1523,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1522\/revisions\/1523"}],"wp:attachment":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/media?parent=1522"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/categories?post=1522"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/tags?post=1522"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}