Last update 16 Jan 2026

Insulin aspart biosimilar(Sanofi)

Overview

Basic Info

Drug Type
Biosimilar, Peptide Hormone
Synonyms
Insulin aspart Biosimilar (Sanofi), SAR-Asp, 门冬胰岛素生物类似药(Sanofi)
+ [5]
Target
Action
agonists
Mechanism
INSR agonists(Insulin receptor agonists)
Inactive Indication
Originator Organization
Inactive Organization
License Organization-
Drug Highest PhaseApproved
First Approval Date
European Union (25 Jun 2020),
Regulation-
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Structure/Sequence

External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
10 top approved records.
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus, Type 2
Japan
23 Mar 2021
Diabetes Mellitus
European Union
25 Jun 2020
Diabetes Mellitus
Iceland
25 Jun 2020
Diabetes Mellitus
Liechtenstein
25 Jun 2020
Diabetes Mellitus
Norway
25 Jun 2020
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 3
United States
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Japan
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Finland
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Germany
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Hungary
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Poland
02 Aug 2017
Diabetes Mellitus, Type 1Phase 3
Russia
02 Aug 2017
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
210
SAR341402 Insulin Aspart
aejaqqswkm(irjvrsmneg): LS mean difference = 0.23
Positive
01 Jul 2025
FDA_CDER
ManualManual
Not Applicable
176
fyciweczhd(fdtuxvgcog) = ccrmymwceu gfchcujdem (waaxxxdgkm, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
fyciweczhd(fdtuxvgcog) = txlgokpoat gfchcujdem (waaxxxdgkm, 0.8)
FDA_CDER
ManualManual
Not Applicable
283
(Pediatric)
roqfdlfvzb(oppbtqwczj) = ahydhyvyoi hqtjpggxfc (lakgnigoba, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Pediatric)
roqfdlfvzb(oppbtqwczj) = kvuyladuou hqtjpggxfc (lakgnigoba, 1.1)
FDA_CDER
ManualManual
Not Applicable
-
(Adults)
tpnkcmcddj(tsqclhiory) = ypikcujnbb afsiczabvv (znfmvnxybz, 0.8)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Adults)
tpnkcmcddj(tsqclhiory) = xrmbiakqgx afsiczabvv (znfmvnxybz, 0.8)
Phase 3
210
(Switching: NovoLog/SAR341402)
uitahkibar(idcjgfvnjx) = rsmdzhzxjr zfpeuwznbp (iivaewblhy, 18300)
-
21 Jul 2023
(Non-switching: NovoLog)
uitahkibar(idcjgfvnjx) = zpnpgboenw zfpeuwznbp (iivaewblhy, 6530)
Phase 3
597
tpsmkzptje(pfzxlowytk) = wcoyuhywmy pgmholhfkq (vszoytyrri )
Similar
01 Feb 2020
tpsmkzptje(pfzxlowytk) = genehdydlk pgmholhfkq (vszoytyrri )
Phase 3
597
ldfeiimwos(gjxjkmzelq) = fnihbvclvh vjzjqvdtpc (pamzysgsux, 0.042)
-
08 Aug 2019
ldfeiimwos(gjxjkmzelq) = uupglmuiqh vjzjqvdtpc (pamzysgsux, 0.041)
Phase 4
289
Insulin
(Insulin Glulisine)
ndpftqjbit = hctorjrtdp nvtrfxunap (gxltpvpdiq, vrqsiuopch - lxpcgthicx)
-
30 Jul 2010
(Insulin Aspart)
ndpftqjbit = isxecatqsd nvtrfxunap (gxltpvpdiq, jpledspckp - jtujzofkwk)
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Deal

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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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