Last update 01 Nov 2024

Insulin aspart biosimilar(Biocon Ltd.)

Overview

Basic Info

Drug Type
Biosimilar, Hormone
Synonyms
Insulin aspart biosimilar - Biocon/Viatris, Kixelle, MYL-1601D
+ [1]
Target
Mechanism
INSR agonists(Insulin receptor agonists)
Active Indication
Inactive Indication
Originator Organization
Inactive Organization
Drug Highest PhaseApproved
First Approval Date
EU (05 Feb 2021),
Regulation-
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External Link

KEGGWikiATCDrug Bank
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R&D Status

Approved
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IndicationCountry/LocationOrganizationDate
Diabetes Mellitus
EU
05 Feb 2021
Diabetes Mellitus
IS
05 Feb 2021
Diabetes Mellitus
LI
05 Feb 2021
Diabetes Mellitus
NO
05 Feb 2021
Developing
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IndicationHighest PhaseCountry/LocationOrganizationDate
Diabetes Mellitus, Type 1Phase 3
US
01 Nov 2018
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Clinical Result

Indication
Phase
Evaluation
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Study
Phase
PopulationAnalyzed EnrollmentGroupResultsEvaluationPublication Date
Phase 3
478
insulin glargine+Insulin aspart
(MYL-1601D)
bxbnmbirmv(vsgzchaxqu) = kapbeldmng niwqocqgnk (mvqrbqfpuo )
Similar
17 Sep 2022
Insulin glargine+Insulin aspart
(Ref-InsAsp-US)
bxbnmbirmv(vsgzchaxqu) = yamxxmdgyv niwqocqgnk (mvqrbqfpuo )
Phase 3
478
(MYL-1601D Product (100 U/mL))
tsbvkijkzt(cqersefnwh) = nrmialdgqa egobgyqwzw (vzdnpvamyb, hxeyfgrjrw - godmvgjnrm)
-
27 Jan 2021
(FlexPen NovoLog® (100 U/mL))
tsbvkijkzt(cqersefnwh) = keworoirms egobgyqwzw (vzdnpvamyb, bauckkxrzb - iolvrigipd)
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Approval

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Regulation

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