{"id":1723,"date":"2016-12-21T12:17:44","date_gmt":"2016-12-21T12:17:44","guid":{"rendered":"https:\/\/www.delveinsight.com\/blog\/?p=1723"},"modified":"2021-07-24T12:56:36","modified_gmt":"2021-07-24T07:26:36","slug":"notizia-19","status":"publish","type":"post","link":"https:\/\/www.delveinsight.com\/blog\/notizia-19","title":{"rendered":"Pfizer uses; FDA approves; EMA approves; Mylan launches"},"content":{"rendered":"<div id=\"ez-toc-container\" class=\"ez-toc-v2_0_76 counter-hierarchy ez-toc-counter ez-toc-white ez-toc-container-direction\">\n<p class=\"ez-toc-title\" style=\"cursor:inherit\">Table of Contents<\/p>\n<label for=\"ez-toc-cssicon-toggle-item-6a06c2c796a9f\" class=\"ez-toc-cssicon-toggle-label\"><span class=\"\"><span class=\"eztoc-hide\" style=\"display:none;\">Toggle<\/span><span class=\"ez-toc-icon-toggle-span\"><svg style=\"fill: #999;color:#999\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" class=\"list-377408\" width=\"20px\" height=\"20px\" viewBox=\"0 0 24 24\" fill=\"none\"><path d=\"M6 6H4v2h2V6zm14 0H8v2h12V6zM4 11h2v2H4v-2zm16 0H8v2h12v-2zM4 16h2v2H4v-2zm16 0H8v2h12v-2z\" fill=\"currentColor\"><\/path><\/svg><svg style=\"fill: #999;color:#999\" class=\"arrow-unsorted-368013\" xmlns=\"http:\/\/www.w3.org\/2000\/svg\" width=\"10px\" height=\"10px\" viewBox=\"0 0 24 24\" version=\"1.2\" baseProfile=\"tiny\"><path d=\"M18.2 9.3l-6.2-6.3-6.2 6.3c-.2.2-.3.4-.3.7s.1.5.3.7c.2.2.4.3.7.3h11c.3 0 .5-.1.7-.3.2-.2.3-.5.3-.7s-.1-.5-.3-.7zM5.8 14.7l6.2 6.3 6.2-6.3c.2-.2.3-.5.3-.7s-.1-.5-.3-.7c-.2-.2-.4-.3-.7-.3h-11c-.3 0-.5.1-.7.3-.2.2-.3.5-.3.7s.1.5.3.7z\"\/><\/svg><\/span><\/span><\/label><input type=\"checkbox\"  id=\"ez-toc-cssicon-toggle-item-6a06c2c796a9f\"  aria-label=\"Toggle\" \/><nav><ul class='ez-toc-list ez-toc-list-level-1 ' ><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-1\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-19\/#For_Inflectra_launch_Pfizer_uses_%E2%80%98hybrid_model_to_home_in_on_HCPs\" >For Inflectra launch, Pfizer uses &#8216;hybrid model&#8217; to home in on HCPs<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-2\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-19\/#US_FDA_approves_Rubraca_to_treat_advanced_ovarian_cancer\" >US FDA approves Rubraca to treat advanced ovarian cancer<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-3\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-19\/#EMA_approves_MSDs_PD-1_therapy_Keytruda_to_treat_patients_with_NSCLC\" >EMA approves MSD\u2019s PD-1 therapy Keytruda to treat patients with NSCLC<\/a><\/li><li class='ez-toc-page-1 ez-toc-heading-level-3'><a class=\"ez-toc-link ez-toc-heading-4\" href=\"https:\/\/www.delveinsight.com\/blog\/notizia-19\/#Mylan_launches_authorized_generic_version_of_EpiPen\" >Mylan launches authorized generic version of EpiPen<\/a><\/li><\/ul><\/nav><\/div>\n<h3><span class=\"ez-toc-section\" id=\"For_Inflectra_launch_Pfizer_uses_%E2%80%98hybrid_model_to_home_in_on_HCPs\"><\/span>For Inflectra launch, Pfizer uses &#8216;hybrid model&#8217; to home in on HCPs<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Pfizer hit the market with Inflectra, a biosimilar of Johnson &amp; Johnson&#8217;s Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same biologic\u2014while required to be \u201chighly similar\u201d\u2014are technically different and come with different datasets and proof points. So, Pfizer went to work to create a new \u201chybrid model\u201d to bring biosimilars to market. Through this model, each biosimilar brand launch will be customized, each will also leverage the scale of the model platform.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"US_FDA_approves_Rubraca_to_treat_advanced_ovarian_cancer\"><\/span>US FDA approves Rubraca to treat advanced ovarian cancer<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The US Food and Drug Administration (FDA) has granted approval to Rubraca (rucaparib) for the treatment of advanced ovarian cancer in women. The poly ADP-ribose polymerase (PARP) inhibitor Rubraca is approved for women who have been treated with two or more chemotherapies and whose tumours have BRCA gene mutation as identified by a companion diagnostic test approved by the FDA. Involved with repairing damaged DNA, BRCA genes normally work to prevent tumour development. Mutations of these genes are expected to lead to certain cancers, including ovarian.Rubraca blocks an enzyme involved in repairing damaged DNA.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"EMA_approves_MSDs_PD-1_therapy_Keytruda_to_treat_patients_with_NSCLC\"><\/span>EMA approves MSD\u2019s PD-1 therapy Keytruda to treat patients with NSCLC<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>The European Medicines Agency\u2019s (EMA) Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion recommending approval of MSD\u2019s Keytruda (pembrolizumab) for the first-line treatment of patients with metastatic non-small-cell lung cancer (NSCLC). Keytruda is an anti-programmed death-1 (PD-1) therapy that blocks the biological pathways cancers use to disguise themselves from the immune system. The drug has been recommended for patients with NSCLC whose tumours have high PD-L1 expression with no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) positive tumour mutations.<\/p>\n<h3><span class=\"ez-toc-section\" id=\"Mylan_launches_authorized_generic_version_of_EpiPen\"><\/span>Mylan launches authorized generic version of EpiPen<span class=\"ez-toc-section-end\"><\/span><\/h3>\n<p>Mylan has launched the authorized generic version of EpiPen (epinephrine injection, USP) auto-injector, after the recent price hike criticism. The self-injectable device (auto-injector) contains epinephrine, the first-line treatment for life-threatening allergic reactions or anaphylaxis. Expected to reach pharmacies from next week, the authorized generic has the same drug formulation and device functionality as EpiPen auto-injector that is administered in the same way. The authorized generic for EpiPen is available in strengths of 0.15 mg and 0.3 mg.<\/p>\n","protected":false},"excerpt":{"rendered":"<p>For Inflectra launch, Pfizer uses &#8216;hybrid model&#8217; to home in on HCPs Pfizer hit the market with Inflectra, a biosimilar of Johnson &amp; Johnson&#8217;s Remicade. And with the launch came not only the beginning of a new class of copycats, but a new way to go to market. Each biosimilar, even versions of the same [&hellip;]<\/p>\n","protected":false},"author":1,"featured_media":1247,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"_acf_changed":false,"_editorskit_title_hidden":false,"_editorskit_reading_time":0,"_editorskit_is_block_options_detached":false,"_editorskit_block_options_position":"{}","advgb_blocks_editor_width":"","advgb_blocks_columns_visual_guide":"","footnotes":""},"categories":[32],"tags":[709,710,412,460,639,595],"industry":[17225],"therapeutic_areas":[17227,17228],"class_list":["post-1723","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-notizia","tag-ema","tag-epipen","tag-mylan","tag-pfizer","tag-pharma-news","tag-usfda","industry-pharmaceutical","therapeutic_areas-immunological-and-autoimmune-disorders","therapeutic_areas-oncology"],"acf":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v25.8 (Yoast SEO v25.8) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Pfizer&#039;s &quot;hybrid model&quot;; Rubraca &amp; Keytruda&#039;s approval; EpiPen&#039;s generic;<\/title>\n<meta name=\"description\" content=\"Pfizer hit the market with Inflectra, a biosimilar of Johnson &amp; Johnson&#039;s Remicade. 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