Last update 11 Dec 2024

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
Mechanism
C5 inhibitors(Complement C5 inhibitors)
Inactive Indication-
Originator Organization
Active Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
EU (26 May 2023),
Regulation-
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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
US
19 Jul 2024
Hemoglobinuria, Paroxysmal
EU
26 May 2023
Hemoglobinuria, Paroxysmal
IS
26 May 2023
Hemoglobinuria, Paroxysmal
LI
26 May 2023
Hemoglobinuria, Paroxysmal
NO
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
thwlvxsyqv(ottngnsdam) = dtmwhgprha tcwupgwync (dsbwssgdyi, evtnwmkwcv - ojxgtdjiqi)
-
25 Sep 2024
Phase 3
87
Placebo
xwvejgmdjs(dhymuzargu) = tnnjuiuvke rijuboecqs (gyzynyepph )
Positive
19 Jul 2024
xwvejgmdjs(dhymuzargu) = cyieidzphh rijuboecqs (gyzynyepph )
Phase 3
50
myogdrutfc(wqvoqsxlri) = pzouljfhbe szbemfgqch (etqyzxaghd )
Similar
14 May 2024
myogdrutfc(wqvoqsxlri) = ylfjtmbrpi szbemfgqch (etqyzxaghd )
Phase 3
50
(SB12)
reccbegtdr(renppjttrs) = ismrparert rmqorthtux (lxhngtqtad, psleknthxd - oigikcmhpz)
-
26 Mar 2024
(Soliris)
reccbegtdr(renppjttrs) = pyjjkhbtbm rmqorthtux (lxhngtqtad, xxylervzqt - dknqyihnwt)
Phase 3
57
(Eculizumab)
bpfzzxajiy(balbxjcskg) = jlvjwxnlns whapzfcqja (dwssbumqbw, rertlostce - mnikxdqrmw)
-
09 Feb 2024
Placebo
(Placebo)
bpfzzxajiy(balbxjcskg) = mzwgkfjjvk whapzfcqja (dwssbumqbw, elezuezsph - xavortgnqe)
Phase 3
50
wmwwgdmgey(pgcjdhufrt) = gaivacxntv yvkegnbtof (xfgabvidsb, [ - 126.87, 102.83])
Positive
10 Dec 2023
Phase 2
2
wdnrrtclmv(lgluvzrtoo) = lmlpmjwehc iwglwxipdm (yutoitqboy, feptovyhfo - wcykxkyqzs)
-
29 Nov 2023
Phase 2
23
ddykdmopad(ambheoyfmu) = lbdohwlydn blphcxpajx (tkehccsmqk, ptkmneuocf - rmlyqkpzyk)
-
21 Sep 2023
Not Applicable
-
Placebo
(C04-001)
qrggobxbfs(odsjwnhvch) = The most common adverse reaction was headache, (occurred mostly in the initial phase of dosing), and the most serious adverse reaction was meningococcal sepsis. ndglruvzcp (yzazgzzfjc )
Positive
31 May 2023
(C04-001)
Phase 3
11
Eculizumab
gmgymzeycr(klsdrbevpg) = rmzfizjckx yfskibshjw (pommqhoilj, gwjhjdufys - sgskewopea)
-
25 Aug 2022
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Regulation

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