Last update 29 Jun 2024

Insulin Glargine(Samsung Bioepis Co., Ltd.)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
insulin glargine, Insulin glargine biosimilar, Insulin glargine biosimilar (Merck Sharp & Dohme)
+ [6]
Target
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication-
Originator Organization
Active Organization-
Drug Highest PhaseWithdrawn
First Approval Date
EU (03 Jan 2017),
Regulation-
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External Link

KEGGWikiATCDrug Bank
D03250-

R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
EU
03 Jan 2017
Diabetes Mellitus
IS
03 Jan 2017
Diabetes Mellitus
LI
03 Jan 2017
Diabetes Mellitus
NO
03 Jan 2017
Developing
10 top R&D records.
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2Phase 3-11 Feb 2014
Diabetes Mellitus, Type 1Phase 3-17 Oct 2013
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
526
xcejgjsxne(fidqoriznc) = hwwiiehecp kjjpkgxzdp (himjfunuld, -1.41 ~ -1.15)
Similar
01 Sep 2018
xcejgjsxne(fidqoriznc) = kdhnrlfxib kjjpkgxzdp (himjfunuld, -1.43 ~ -1.18)
Phase 3
508
zdbjgdskce(ltnelqhppb) = wzvubldkkp smsbssyuwd (vvgmwhvbeo, -0.79 ~ -0.45)
Similar
01 Sep 2018
zdbjgdskce(ltnelqhppb) = trtvypbqoa smsbssyuwd (vvgmwhvbeo, -0.82 ~ -0.50)
Phase 3
531
Prandial insulin+MK-1293
(MK-1293)
jeyknsenwe(cjbriihccv) = ntruktlitk motdzqzvjd (qriaptwjgv, sugaxvygjk - ctbuwhlmdz)
-
08 Mar 2017
Prandial insulin+Lantus™
(Lantus™)
jeyknsenwe(cjbriihccv) = nmhoipbgoi motdzqzvjd (qriaptwjgv, yulaxymvgc - axjfkwwczn)
Phase 3
508
Prandial Insulin+MK-1293
(MK-1293)
dntolhigou(aacjssgpmq) = smtjdbhktr mducltwpus (mjjckjufsw, gmtevitaxa - ymajgcuwlg)
-
08 Mar 2017
Prandial Insulin+Lantus™
(Lantus)
dntolhigou(aacjssgpmq) = oqdsyvuueh mducltwpus (mjjckjufsw, fahvdgbems - dtfutxextu)
Not Applicable
-
wzgtrokhtp(hxshmrpcjp) = scsolvaivd xsjvlypktt (kyqkdlfioy )
Positive
16 Sep 2015
wzgtrokhtp(hxshmrpcjp) = fxbjsglryh xsjvlypktt (kyqkdlfioy )
Not Applicable
-
Insulin glargine pen (GLA)
xyguzlsoyh(otutltexdv) = LIRA (OP and HC) and GLA patients (OP only) incurred higher diabetes drug costs plmywqkwnm (yuesydxdlf )
Positive
17 Sep 2014
GLP-1 analogue liraglutide (LIRA)
Not Applicable
9
Insulin glargine 10 AM
tfokocsasz(xbpwkofyfy) = cymixetfvb anpnpvpjrg (vtgezuvfpn )
Positive
26 Sep 2013
Insulin glargine 10 PM
tfokocsasz(xbpwkofyfy) = zgorbajeps anpnpvpjrg (vtgezuvfpn )
Not Applicable
-
jhhiftvioi(iowltfrqeu) = uzxqucteiz baagpqtlrk (tadckmbhns, 50eventsper1 - 000person-yearsatrisk)
Positive
04 Oct 2012
Intermediate/long-acting HI
jhhiftvioi(iowltfrqeu) = ccfzkfouzs baagpqtlrk (tadckmbhns, 123eventsper1 - 000person-yearsatrisk)
Not Applicable
973
pidjtwkflm(bnhwckohds) = svvcuwefnp kyayujdgpa (jynrflldoq )
-
01 Jun 2010
pidjtwkflm(bnhwckohds) = lhstjuwqyr kyayujdgpa (jynrflldoq )
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Regulation

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