Will Epoetin Biosimilar Serve As Non-Medical Switching Case Study?
Executive Summary
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...
Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching
Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
Biosimilars: US FDA Education Campaign Is Non-Committal On Non-Medical Switching
Substituting a biosimilar for a reference product is a state issue and outside agency's purview, FDA says.
Biosimilar Advisory Committees Getting Smoother, Even As Worries Stay The Same
US FDA advisors overwhelming endorse Hospira's biosimilar referencing Amgen's Epogen, but still wanted broader immunogenicity data and postmarketing surveillance.