Will Epoetin Biosimilar Serve As Non-Medical Switching Case Study?
Analysts expect potential broad uptake of biosimilars in chronic kidney disease treated at dialysis centers, which could lead to patients being switched off Amgen's Epogen.
You may also be interested in...
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.
US FDA will hold its first-ever half-day panel review for a biosimilar; Hopsira's epoetin, which references Amgen's Epogen, has no clinically meaningful differences despite clinical trial conduct issues and PK/PD uncertainty, agency concludes.
Express Scripts’ Eichholz says clinicians may be less inclined to use a biosimilar in ‘life or death’ oncology indications compared to inflammatory diseases.