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 · Company profile
FDADec 2021approved
EMASep 2014authorised
MHRALicenseddate not shown
PMDADec 2014approved
HCSep 2015approved
CDSCOAug 2017permitted
EDENot listed
Approved or registered in 6 of 7 markets
Connections
About Rezvoglar / Abasaglar
Lilly's insulin glargine has a different name and status in each market. In Europe it is Abasaglar, the first biosimilar insulin approved there, in 2014. In the United States it was sold as Basaglar from 2016 through the older drug route, and a separately approved biosimilar version, Rezvoglar, became interchangeable in 2022. Canada and India know it as Basaglar, and Japan approved it under Lilly's name in 2014 as its first biosimilar insulin.
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
Reference product in the Purple Book
Lantus
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 U/mL, 3 mL pen
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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
Remarks
First EU biosimilar insulin; originally named Abasria.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Abasaglar
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Abasaglar
Holder or applicant
Not shown in the MHRA substance list
Pathway
UK marketing authorisation (Great Britain and, for EU-converted licences, Northern Ireland)
Approved
not published
Presentations
100 units/mL KwikPen, Tempo Pen and cartridge
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Insulin Glargine BS [Lilly]
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Insulin Glargine BS [Lilly]
Holder or applicant
Eli Lilly Japan
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Dec 2014
Indications as licensed
Diabetes mellitus requiring insulin
Presentations
Cartridges and MirioPen
Remarks
Insulin Glargine Biosimilar 1, the first biosimilar insulin in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Basaglar
Health CanadaApprovedBrand
Basaglar
Holder or applicant
Eli Lilly Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Sep 2015
Application or permission
DIN 02444844, 02444852, 02461528
Presentations
100 units/mL
Source
S022 (Health Canada) · checked Sep 2026
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 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Rezvoglar / Abasaglar holds an approval, these are the other insulin glargine biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 2 | Biocon Biologics (Semglee), Sunshine Lake Pharma (Langlara) |
| EMA | 2 | Biocon Biologics (Semglee), Gan & Lee Pharmaceuticals (Ondibta) |
| MHRA | 1 | Biocon Biologics (Semglee) |
| PMDA | 1 | Biocon Biologics (Semglee) |
| HC | 1 | Biocon Biologics (Semglee) |
| CDSCO | 9 | Biocon Biologics (Semglee), Cipla (Cipla insulin glargine), Eris Lifesciences (Eris insulin glargine), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Regenix (Regenix insulin glargine), Wockhardt (Wockhardt insulin glargine) |
Chronology
- EMASep 2014Authorised by the European Commission as Abasaglar
- PMDADec 2014Approved by MHLW as Insulin Glargine BS [Lilly]
- HCSep 2015Notice of Compliance, Health Canada as Basaglar
- 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)S020PMDA, list of approved biosimilar products in Japan (as of July 2026) Primary (regulator)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
Planning insulin glargine biosimilar development?
EvySaif can help assess your regulatory pathway, clinical evidence requirements and market-entry strategy across India, UAE and other target markets.
Talk to a biosimilar regulatory consultantData current to September 2026.