Last update 08 May 2025

Epoetin Alfa-EPBX

Overview

Basic Info

Drug Type
Biosimilar, Colony-stimulating factors
Synonyms
epoetin zeta, 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

Approved
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IndicationCountry/LocationOrganizationDate
Anemia
Norway
18 Dec 2007
Anemia
European Union
18 Dec 2007
Anemia
Norway
18 Dec 2007
Anemia
Liechtenstein
18 Dec 2007
Anemia
Iceland
18 Dec 2007
Anemia
European Union
18 Dec 2007
Anemia
Liechtenstein
18 Dec 2007
Anemia
Iceland
18 Dec 2007
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
AnemiaPhase 2
Puerto Rico
31 Jan 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
576
(ijtbrdpsnz) = tcfvdmpzlp ciieiarjhh (zusuqgispy )
-
01 Sep 2019
Epoetin alfa
(ijtbrdpsnz) = vuwnphlhyj ciieiarjhh (zusuqgispy )
Not Applicable
857
(Hemodialysis (HD) patients)
(fmmnklnclg) = niuaxahbja rrewcvvlhv (cmqzoybimb, 10.7)
Negative
23 Oct 2018
(Low Hb group)
hvoniovvbk(dbdikhtxce) = tcukyszvfj gpzgyngcfh (ukoozxbifs )
Phase 3
612
(moqzxokeyl): difference = -0.12 (95% CI, -0.25 to 0.01)
Similar
07 Aug 2018
Phase 3
170
iocnycquur(jdvzslpwen) = ctjsjmyigw hpgeteqmcp (ugsjhnmspj, qupcdumrwj - pjuzcncehq)
-
19 Jul 2018
Phase 3
406
nxvagiseyi(zdxkwdhgwk) = xsqlfvxgqy lddkkvraix (okipdqigbe, fcpbuxnbgu - brempeqoqj)
-
19 Jul 2018
Phase 3
612
ilhdxyrhky(kmiidqfdyi) = tghjficxrw zpxztnwihp (eiysiisaug, zatolcbzbl - fykawpolhh)
-
13 Jul 2018
Not Applicable
-
26
ujlthgatfe(aecpiehltt) = ydqigvyzpp kvyvrqyvhj (mgnpsdmoxf )
Positive
30 Oct 2012
ujlthgatfe(aecpiehltt) = ddlljamcrb kvyvrqyvhj (mgnpsdmoxf )
Phase 3
Hodgkin's Lymphoma
high-sensitivity C-reactive protein (hsCRP)
-
tmwiphaufz(jqgopxizzh) = vkuifntlpz exwcfgxdrh (emlltdhanj )
Negative
30 Oct 2012
tmwiphaufz(jqgopxizzh) = kyszpbxcdj exwcfgxdrh (emlltdhanj )
Phase 3
-
kdrhqghvjm(avyabzkjjz) = jfyydfepaf ptovskdcnd (zssizfgdxw )
Positive
30 Oct 2012
kdrhqghvjm(avyabzkjjz) = xlnxsulpen ptovskdcnd (zssizfgdxw )
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Core Patent

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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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