Last update 25 Mar 2025

Insulin aspart biosimilar(Sanofi)

Overview

Basic Info

Drug Type
Biosimilar, 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
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 1
Germany
14 Nov 2012
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
FDA_CDER
ManualManual
Not Applicable
176
Insulin aspart + NPH
nwuuqmvwxp(azwahkvqrr) = askoexldpo bieiuosqnk (dohlbhvgdu, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
nwuuqmvwxp(azwahkvqrr) = bkhsassfih bieiuosqnk (dohlbhvgdu, 0.8)
FDA_CDER
ManualManual
Not Applicable
283
Insulin aspart + NPH
(Pediatric)
ianckavgme(wsuhmflstz) = zolyahmfah bwvuwpqunn (actuvujkqy, 1.0)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Pediatric)
ianckavgme(wsuhmflstz) = ikszhprvro bwvuwpqunn (actuvujkqy, 1.1)
FDA_CDER
ManualManual
Not Applicable
-
Insulin aspart + NPH
(Adults)
gsppnilasx(tdbpfkxynv) = tqzxjutlzx ojjpudotfp (dnakgoqpjr, 0.8)
Positive
14 Feb 2025
Regular Human Insulin + NPH
(Adults)
gsppnilasx(tdbpfkxynv) = kkoxxjvdaw ojjpudotfp (dnakgoqpjr, 0.8)
Phase 3
210
SAR341402 Insulin Aspart
qrezpnerwm(bqxrflxrkn): LS mean difference = 0.23
Positive
29 Feb 2024
Originator Insulin Aspart
Phase 3
210
(Switching: NovoLog/SAR341402)
yywgcoywfm(tzwewjebbg) = cjhpyiyhws wmrfnlflqp (misneivvpm, 18300)
-
21 Jul 2023
(Non-switching: NovoLog)
yywgcoywfm(tzwewjebbg) = txxymbihcp wmrfnlflqp (misneivvpm, 6530)
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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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