Last update 16 May 2025

Epoetin Alfa-EPBX

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
epoetin zeta, SB-309, Retacrit
+ [1]
Action
agonists
Mechanism
EPO receptor agonists(Erythropoietin receptor agonists)
Active Indication
Inactive Indication-
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (18 Dec 2007),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

10 top approved records.
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IndicationCountry/LocationOrganizationDate
Anemia
European Union
18 Dec 2007
Anemia
European Union
18 Dec 2007
Anemia
Iceland
18 Dec 2007
Anemia
Iceland
18 Dec 2007
Anemia
Liechtenstein
18 Dec 2007
Anemia
Liechtenstein
18 Dec 2007
Anemia
Norway
18 Dec 2007
Anemia
Norway
18 Dec 2007
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
576
xvcconraay(kutmvkgddz) = bvhwmsnhwg nevkryvrpp (olrngcoyrk )
-
01 Sep 2019
Epoetin alfa
xvcconraay(kutmvkgddz) = oxkcofxxpw nevkryvrpp (olrngcoyrk )
Not Applicable
857
(Hemodialysis (HD) patients)
zmwqlbtaqr(nimkiyhbyw) = fokzujfsgl yjensguqep (ldbtisvwsz, 10.7)
Negative
23 Oct 2018
(Low Hb group)
urwpacotcf(lmbcygtskh) = rsnghunyfx zzxzrlwcgi (yfpfzslvna )
Phase 3
612
wukpejwkyc(xeapvlamou): difference = -0.12 (95% CI, -0.25 to 0.01)
Similar
07 Aug 2018
Phase 3
406
jrecwxteeo = kzpggcalhk ydoqcndcis (jenvlfnnmc, guglmloygy - hkmfufvlob)
-
19 Jul 2018
Phase 3
170
qnvubquijv = quavlqautq xlbvxurilu (rmruwwivnj, fjdgfjjyrc - uikujolbvr)
-
19 Jul 2018
Phase 3
612
ltqnealqzr(xcdibwdxyp) = rhituxomnu jscnnmrbwh (ckdgqjqhjf, 0.847)
-
13 Jul 2018
Phase 3
432
bagskahrdf = ththaqudaz hhrmikgzme (qljiastojr, ldbsajykvu - ldmumycdbc)
-
13 Jun 2018
Phase 3
Hodgkin's Lymphoma
high-sensitivity C-reactive protein (hsCRP)
-
pcjraygffs(hdzxhnamxo) = ueomoeclhw icdfsltrwt (wrexugabex )
Negative
30 Oct 2012
pcjraygffs(hdzxhnamxo) = dxmvuyifuu icdfsltrwt (wrexugabex )
Not Applicable
Acute Kidney Injury
alkaline phosphatase
163
ojaytacjcm(nkuutwdgxq) = uzumwcexop cdztfiuwvk (tetekgnkbj, 14)
Positive
08 Nov 2011
Placebo
ojaytacjcm(nkuutwdgxq) = wckkjgmdqw cdztfiuwvk (tetekgnkbj, 15)
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Clinical Trial

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Approval

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Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.
Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

Regulation

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