Rezvoglar / Abasaglar
Insulin glargine biosimilar developed by Eli Lilly (with Boehringer Ingelheim), development code LY2963016. Reference product Lantus.
Brands by market: Rezvoglar (USA); Abasaglar (EU); Basaglar (India, import) · Commercial partner or holder: Eli Lilly
FDADec 2021approved
EMASep 2014authorised
CDSCOAug 2017permitted
EDEnot listed
Status by market
FDA
United States · Rezvoglar
US Food and Drug AdministrationApprovedBrand
Rezvoglar
Holder or applicant
Eli Lilly and Company
Pathway
351(k)
Approved
Dec 2021
Application or permission
761215
Licence type
351(k) interchangeable, designated Nov 2022
Presentations
100 U/mL, 3 mL pen
Source
S001, S016
EMA
European Union · Abasaglar
European Medicines Agency and European CommissionApprovedBrand
Abasaglar
Holder or applicant
Eli Lilly Nederland B.V.
Pathway
Centralised (Article 10(4))
Approved
Sep 2014
Application or permission
EMEA/H/C/002835
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 2 years
Presentations
see SmPC
Note
First EU biosimilar insulin; originally named Abasria.
Source
S017
CDSCO
India · Basaglar
Central Drugs Standard Control OrganisationApprovedBrand
Basaglar
Holder or applicant
Eli Lilly and Company (India) Pvt Ltd
Pathway
Import and marketing permission
Approved
Aug 2017
Application or permission
Import permission
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 2 years
Presentations
100 U/mL, 3 mL cartridge and pre-filled pen
Source
S013
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMASep 2014Authorised by the European Commission as Abasaglar
- CDSCOAug 2017CDSCO permission granted as Basaglar
- FDADec 2021Approved by FDA as Rezvoglar
- FDANov 2022Rezvoglar designated interchangeable
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)S013CDSCO, import and market permissions till 2019 (r-DNA) Primary (regulator)
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