{"id":1017,"date":"2025-05-29T06:06:55","date_gmt":"2025-05-29T06:06:55","guid":{"rendered":"https:\/\/www.udenyca.com\/cms\/?page_id=1017"},"modified":"2026-01-08T12:50:56","modified_gmt":"2026-01-08T12:50:56","slug":"established-outcomes","status":"publish","type":"page","link":"https:\/\/www.udenyca.com\/cms\/hcp-home\/established-outcomes\/","title":{"rendered":"ESTABLISHED OUTCOMES"},"content":{"rendered":"","protected":false},"excerpt":{"rendered":"","protected":false},"author":2,"featured_media":0,"parent":856,"menu_order":0,"comment_status":"closed","ping_status":"closed","template":"","meta":{"_acf_changed":false,"footnotes":""},"class_list":["post-1017","page","type-page","status-publish","hentry"],"acf":{"banner_section":{"background_image":1054,"heading":"UDENYCA<sup>&reg;<\/sup> provides the <span className=\"yellowtxt\">established outcomes <\/span>you expect for your patients                     ","background_image_url":"https:\/\/www.udenyca.com\/cms\/wp-content\/uploads\/2025\/05\/why-udenyca-hero.svg"},"section_2":{"heading":"UDENYCA<sup>\u00ae<\/sup> was confirmed to be highly similar to Neulasta<sup>\u00ae<\/sup>\u202f(pegfilgrastim), with no clinically meaningful differences.<sup>1,2<\/sup> ","desktop_image":1057,"mobile_image":1058,"bottom_text":"* The assays used to assess immunogenicity for UDENYCA were highly sensitive and demonstrated no treatment-emergent neutralizing antibodies in more than 300 subjects. ","desktop_image_url":"https:\/\/www.udenyca.com\/cms\/wp-content\/uploads\/2025\/05\/Web-Asset-Established-Outcomes.svg","mobile_image_url":"https:\/\/www.udenyca.com\/cms\/wp-content\/uploads\/2025\/05\/Mobile-Asset-Established-Outcomes.svg"},"section_3":{"heading":"Approval based on extensive data analysis and stringent FDA requirements<sup>3<\/sup>","description":"<p>Clinical studies with UDENYCA were conducted in healthy subjects, the most sensitive and informative population in which to assess biosimilarity.<sup>4<\/sup><\/p>\r\n<ul>\r\n<li>A study in healthy subjects is likely to produce less pharmacokinetic\/pharmacodynamic variability compared to a study in patients with potential confounding factors, such as underlying and\/or concomitant disease and concomitant medications, such as myelosuppressive chemotherapy<\/li>\r\n<li>Healthy subjects are fully immunocompetent and can mount an immune antidrug antibody response<\/li>\r\n<li>Lack of confounding factors in healthy subjects allows for better evaluation of treatment-related adverse events that are specific to pegfilgrastim<\/li>\r\n<\/ul>\r\n<p>Clinical studies in cancer patients to confirm biosimilarity of UDENYCA\u202fto Neulasta<sup>\u00ae<\/sup> were not required by the FDA.<\/p>","bottom_text":"<small>ADA = antidrug antibody; adverse events = AE; PK\/PD = pharmacokinetic\/pharmacodynamic.<\/small>"},"section_4":{"heading":"Establishing biosimilarity for UDENYCA","sub_heading":"The FDA recommends a stepwise approach for biosimilar development<sup>3,4<\/sup>","desktop_image":1062,"mobile_image":1061,"desktop_image_url":"https:\/\/www.udenyca.com\/cms\/wp-content\/uploads\/2025\/05\/Asset-Established-Outcomes.svg","mobile_image_url":"https:\/\/www.udenyca.com\/cms\/wp-content\/uploads\/2025\/05\/Mob_Asset-Established-Outcomes.svg"},"section_5":{"box_1":{"heading":"THREE ADMINISTRATION OPTIONS","description":"UDENYCA offers multiple administration options so you can prescribe based on the needs of your patients.","button_text":"Explore administration options","button_link":"\/hcp\/administration-options"},"box_2":{"heading":"RECOMMENDATIONS FOR USE ","description":"Practice guidelines suggest pegfilgrastim use in appropriate patients to\u202fsupport clinical outcomes\u202fduring chemotherapy.<sup>5<\/sup>\r\n                            ","button_text":"See the guidelines","button_link":"\/hcp\/why-udenyca"},"box_3":{"heading":"ACCESS & SUPPORT","description":"AccordCares<sup>&reg;<\/sup> provides patient support services designed to help remove hurdles to help access UDENYCA<sup>\u00ae<\/sup>.","button_text":"Discover patient support","button_link":"\/hcp\/patient-support-services"}}},"banners":[],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v24.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>UDENYCA\u00ae Established Outcomes \u2013 Proven Efficacy in Neutropenia Prophylaxis<\/title>\n<meta name=\"description\" content=\"UDENYCA\u00ae (pegfilgrastim-cbqv) demonstrates established outcomes in reducing febrile neutropenia risk. 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