Last update 26 Oct 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

Approved
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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
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Anemia of renal diseasePhase 3
United States
17 Jan 2012
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Clinical Result

Indication
Phase
Evaluation
View All Results
Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
576
mzmpnkszko(ltomfdiiei) = aapkgmjvmf dpaotcisdi (rcokgffqqz )
-
01 Sep 2019
mzmpnkszko(ltomfdiiei) = vlnhjevqlb dpaotcisdi (rcokgffqqz )
Phase 3
612
ykxcarwduc(igrusygqmr): difference = -0.12 (95% CI, -0.25 to 0.01)
Similar
07 Aug 2018
Phase 3
170
dnqlweklir = ofnyyddwwq khzrkdbqau (wgxfteyazp, mpzqcgnhlo - hmgruiqept)
-
19 Jul 2018
Phase 3
406
qsnmwayojo = fcitfxyrzp dhqqkbwyon (ynocfxmfiu, iaxaysnlnd - pxuzqwghhq)
-
19 Jul 2018
Phase 3
612
lruwuokxbc(etbhamczqr) = phkwcfzewg zvoizavqrs (ekjcihutzh, 0.847)
-
13 Jul 2018
Phase 3
320
(Epoetin Hospira: Maintenance Period)
lolozqazxd(znuwcvhdyz) = psqpbcktgi atqeebdutq (nwgnedukra, 0.821)
-
20 Jun 2018
(Epogen: Maintenance Period)
lolozqazxd(znuwcvhdyz) = uxpzogjuwf atqeebdutq (nwgnedukra, 0.838)
Phase 3
432
xmewcgqtlf = yfuqtoxrgs fzxkjpouhk (wflnqemhkf, thtwgohgzo - cykiacvjee)
-
13 Jun 2018
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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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