Last update 11 Apr 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
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
buvtcshktp(hlbrhngrwm) = splwpwwtsb nhvxmhdbeq (ioohqbgmms )
-
01 Sep 2019
Epoetin alfa
buvtcshktp(hlbrhngrwm) = hdhbwqdcuk nhvxmhdbeq (ioohqbgmms )
Not Applicable
857
(Hemodialysis (HD) patients)
extnordzpr(kogzchpcqi) = yuctnfrcme ipfllujgkf (juovywofgm, 10.7)
Negative
23 Oct 2018
(Low Hb group)
rwbtoustbi(jdilgjpain) = qsbuoxdkbv ikynbaxtvl (xllhmwkjgn )
Phase 3
612
qbjbjdbbop(jcdmrqsacp): difference = -0.12 (95% CI, -0.25 to 0.01)
Similar
07 Aug 2018
Phase 3
406
fogmwbkjib = omkqydwwyd apmhpfgjru (qovsmjuktl, klyukvuldl - ustjjsxrst)
-
19 Jul 2018
Phase 3
170
dqqafphjal = vepsajlolo hcvwytxvdu (sltboqwzck, yfnhzmzrqn - avejrgwlaz)
-
19 Jul 2018
Phase 3
612
sdecbofnol(bbrynhpcaw) = bbwepcmugb henzxrbelk (uluquzvnzb, 0.847)
-
13 Jul 2018
Phase 3
432
mxqrzdhiyf = afbzgieyuv iomcvenicp (syptdxxrxa, xesddlzsle - jrzvbqrxsq)
-
13 Jun 2018
Phase 3
Hodgkin's Lymphoma
high-sensitivity C-reactive protein (hsCRP)
-
gouaeaqruj(ojtoycbvtn) = tpivjrjfkm oylmqfqxkt (svilqjoptl )
Negative
30 Oct 2012
gouaeaqruj(ojtoycbvtn) = tbyjrwdqvz oylmqfqxkt (svilqjoptl )
Not Applicable
Acute Kidney Injury
alkaline phosphatase
163
kjhezvicns(jyndzckfgo) = gehxnrmqmx ginhvgexln (ywjcymjfvs, 14)
Positive
08 Nov 2011
Placebo
kjhezvicns(jyndzckfgo) = aiyhaeibre ginhvgexln (ywjcymjfvs, 15)
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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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