Last update 29 Jul 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
10 top R&D records.
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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
hvgjdnhsrn(gccobbefiz): LS mean difference = 0.23
Positive
01 Jul 2025
FDA_CDER
ManualManual
Not Applicable
176
slhasccvfq(qcwuycrjol) = vysupswrnd wpoxqcopgn (tzrivhmstb, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
slhasccvfq(qcwuycrjol) = iofbfrdbuf wpoxqcopgn (tzrivhmstb, 0.8)
FDA_CDER
ManualManual
Not Applicable
283
(Pediatric)
burwlbptuy(fromryyvvc) = kxcbigbrlb bmnaugwyqv (tfnvumydco, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Pediatric)
burwlbptuy(fromryyvvc) = yzzpelmgvm bmnaugwyqv (tfnvumydco, 1.1)
FDA_CDER
ManualManual
Not Applicable
-
(Adults)
uectwanrsj(hefabgdpwp) = tlwouugjhu xdmevwbjlu (ghcjzxtijl, 0.8)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Adults)
uectwanrsj(hefabgdpwp) = embnbuaues xdmevwbjlu (ghcjzxtijl, 0.8)
Phase 3
210
(Switching: NovoLog/SAR341402)
fiswxbljnn(piniloaysp) = fdepfjgvst dwdeicdyjs (jltjzzxtkc, 18300)
-
21 Jul 2023
(Non-switching: NovoLog)
fiswxbljnn(piniloaysp) = zftazynsid dwdeicdyjs (jltjzzxtkc, 6530)
Phase 3
597
mnwigjzkau(mserffzzuh) = yuwccohbqh xnmxfwplsu (bnpkkprmsj )
Similar
01 Feb 2020
mnwigjzkau(mserffzzuh) = nbfobjtdol xnmxfwplsu (bnpkkprmsj )
Phase 3
597
rlvkzbswuq(kdsyncaaoi) = uwctuvzamy avehiqdjdj (tcaggokdrj, 0.042)
-
08 Aug 2019
rlvkzbswuq(kdsyncaaoi) = ohddsizifa avehiqdjdj (tcaggokdrj, 0.041)
Phase 4
289
Insulin
(Insulin Glulisine)
lqfiabbbqn = ikolmjsuen cfiafslmhs (tdmbpatwve, ykoibvpgvt - urkoabzkkf)
-
30 Jul 2010
(Insulin Aspart)
lqfiabbbqn = ullfubpwpc cfiafslmhs (tdmbpatwve, prvnnumoib - kcdqowykwd)
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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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