Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen\u2019s EU-licensed Neulasta (pegfilgrastim) \u2013 a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF).<\/p>\n
Sandoz is seeking approval for the same indication as the reference product.<\/p>\n
Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and myelodysplastic syndromes) to help with some of the side effects of their treatment. It reduces the duration of neutropenia and the incidence of febrile neutropenia that are a result of their chemotherapy treatment. The incidence of febrile neutropenia occurring with common chemotherapy regimens is 25 to 40% of treatment-naive patients.<\/p>\n
\u201cSandoz is the leading provider of daily G-CSF in Europe and the regulatory filing of our biosimilar pegfilgrastim further cements our commitment to patients undergoing cancer treatment\u201d said Mark McCamish, M.D., Ph.D., and Head of Global Biopharmaceutical & Oncology Injectables Development at Sandoz. \u00a0\u201cIf approved, physicians in the EU will have another high-quality Sandoz biosimilar treatment option for patients needing granulocyte colony-stimulating factors\u201d McCamish continued.<\/p>\n
Sandoz believes that the totality of evidence in its submission, including three pivotal clinical trials \u2013 one pharmacokinetic and pharmacodynamic study in healthy volunteers and two comparative efficacy and safety studies in breast cancer patients \u2013 is expected to satisfy the regulatory requirements for demonstrating high similarity to the reference product and therefore justifies use of biosimilar pegfilgrastim in the reference product\u2019s indication.<\/p>\n
Source: Sandoz Press release<\/p>\n","protected":false},"excerpt":{"rendered":"
Sandoz, announced that EMA has accepted their Marketing Authorization Application for its biosimilar to Amgen\u2019s EU-licensed Neulasta (pegfilgrastim) \u2013 a long-acting recombinant human granulocyte colony-stimulating factor (G-CSF). Sandoz is seeking approval for the same indication as the reference product. Pegfilgrastim is a prescription medicine used in cancer patients (except those with chronic myeloid leukemia and […]<\/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":[],"tags":[],"class_list":["post-1261","post","type-post","status-publish","format-standard","hentry"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1261","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=1261"}],"version-history":[{"count":2,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1261\/revisions"}],"predecessor-version":[{"id":1265,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/posts\/1261\/revisions\/1265"}],"wp:attachment":[{"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/media?parent=1261"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/categories?post=1261"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/medizone.com\/en\/wp-json\/wp\/v2\/tags?post=1261"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}