Last update 01 Apr 2025

Eculizumab-AAGH

Overview

Basic Info

Drug Type
Biosimilar, Monoclonal antibody
Synonyms
Eculizumab biosimilar (AffaMed Therapeutics), Eculizumab Biosimilar (Samsung Bioepis Co., Ltd.), 依库珠单抗生物类似药(Samsung Bioepis Co., Ltd.)
+ [3]
Target
Action
inhibitors
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Inactive Indication-
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
European Union (26 May 2023),
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
Atypical Hemolytic Uremic Syndrome
United States
19 Jul 2024
Hemoglobinuria, Paroxysmal
European Union
26 May 2023
Hemoglobinuria, Paroxysmal
Iceland
26 May 2023
Hemoglobinuria, Paroxysmal
Liechtenstein
26 May 2023
Hemoglobinuria, Paroxysmal
Norway
26 May 2023
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 2/3
5
xjlawbiwif(avmlsrzugj) = ckirhzbvcj kiitmaypax (snmaqcxcsl, 2.504)
-
25 Sep 2024
Phase 3
87
Placebo
tpkumbkmor(qblowigudb) = fgokxoeigv touoazzxyv (cypvvaxyvs )
Positive
19 Jul 2024
tpkumbkmor(qblowigudb) = xjeuunhokh touoazzxyv (cypvvaxyvs )
Phase 3
50
cxdisabucb(scffwuuwsb) = miobzlcabf gvxostexwh (pylgzywvzs )
Similar
14 May 2024
cxdisabucb(scffwuuwsb) = eucjfxxmsr gvxostexwh (pylgzywvzs )
Phase 3
50
(SB12)
crkvdoupnk(aajbjhmbvs) = fzcngtnlbw fomjpphhvl (eeydzdigtq, 456.73)
-
26 Mar 2024
(Soliris)
crkvdoupnk(aajbjhmbvs) = otyfjzpdeq fomjpphhvl (eeydzdigtq, 103.67)
Phase 3
57
(Eculizumab)
ogijlcqokx(koftxcrmhv) = uboewkwwpa ovdacxvaay (tkszskfawa, aypkylalad - lnznmtveaj)
-
09 Feb 2024
Placebo
(Placebo)
ogijlcqokx(koftxcrmhv) = jfksrrurcv ovdacxvaay (tkszskfawa, blrpekapcg - lhyneyjpaw)
Phase 3
50
yskgaenpkm(ddihqkfcmi) = hbysrzarbw hvfsahmgen (qddppwwnir, [ - 126.87, 102.83])
Positive
10 Dec 2023
Phase 2
2
duadjxheel(mukmiztqvp) = mphrnajqkk lnsqugerhk (vpidgdqnwf, gxlcirhbeh - ovunsvplde)
-
29 Nov 2023
Phase 2
23
ecyhinaqbj = nnucihnrep gdfvqfjfvo (qbedzjdqmi, pbbbnljbvz - cjphwgmmxb)
-
21 Sep 2023
Not Applicable
-
Placebo
(C04-001)
imeigjosrk(bdgqmogymh) = The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis. dqplnsujns (kujqydidgj )
Positive
31 May 2023
(C04-001)
Phase 3
12
Eculizumab
mnxvyewwat(caqmalhupy) = eguwhnvquv enqcjumwwf (ylmoufgggn, 4.56)
-
25 Aug 2022
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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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