Will There Be a Role for a Short-Acting Biosimilar Erythropoiesis-Stimulating Agent in US Nephrology Practice?

dc.contributor.authorWish, Jay B.
dc.contributor.departmentMedicine, School of Medicineen_US
dc.date.accessioned2019-12-20T19:45:34Z
dc.date.available2019-12-20T19:45:34Z
dc.date.issued2019-07-11
dc.description.abstractPatent protection for pharmaceuticals in the United States is very robust and perhaps there is no greater example than epoetin alfa. Since the approval of epoetin alfa by the Food and Drug Administration (FDA) in 1989, the developer, Amgen (Thousand Oaks, CA), has successfully defended its patent against competing agents, such as epoetin beta (Chugai-Upjohn, Rosemont, IL), epoetin delta (Shire, Lexington, MA), and methoxy polyethylene glycol-epoetin beta (CERA; Roche, Basel, Switzerland). The US patent on epoetin alfa expired in 2015, opening the way for competition by products other than Amgen’s own darbepoetin. The first non-Amgen erythropoiesis-stimulating agent (ESA) to enter the US market was CERA, which had previously been approved by the FDA as a new drug under a biologic license application 351(a). Drugs approved through the 351(a) pathway must undergo expensive clinical testing, the cost of which is ultimately passed on to the consumer. ESAs are biologic drugs, defined by the FDA as “a virus, therapeutic serum, toxin, antitoxin, blood, blood component or derivative, allergenic product, protein (except any chemically synthesized polypeptide), or analogous product . . . applicable to the prevention, treatment of cure of a disease or condition of human beings.”en_US
dc.identifier.citationWish J. B. (2019). Will There Be a Role for a Short-Acting Biosimilar Erythropoiesis-Stimulating Agent in US Nephrology Practice?. Kidney international reports, 4(9), 1199–1202. doi:10.1016/j.ekir.2019.07.004en_US
dc.identifier.urihttps://hdl.handle.net/1805/21524
dc.language.isoen_USen_US
dc.publisherElsevieren_US
dc.relation.isversionof10.1016/j.ekir.2019.07.004en_US
dc.relation.journalKidney International Reportsen_US
dc.rights.urihttps://creativecommons.org/licenses/by-nc/4.0*
dc.sourcePMCen_US
dc.subjectPatent protectionen_US
dc.subjectEpoetin alfaen_US
dc.subjectBiologicsen_US
dc.titleWill There Be a Role for a Short-Acting Biosimilar Erythropoiesis-Stimulating Agent in US Nephrology Practice?en_US
dc.typeArticleen_US
Files
Original bundle
Now showing 1 - 1 of 1
Loading...
Thumbnail Image
Name:
main-1.pdf
Size:
137.73 KB
Format:
Adobe Portable Document Format
Description:
License bundle
Now showing 1 - 1 of 1
No Thumbnail Available
Name:
license.txt
Size:
1.99 KB
Format:
Item-specific license agreed upon to submission
Description: