Semglee
Insulin glargine biosimilar developed by Biocon Biologics (with Mylan / Viatris), development code MYL-1501D. Reference product Lantus.
Brands by market: Semglee (USA, EU, UAE); Basalog (India, Biocon) · Commercial partner or holder: Biocon Biologics
FDAJul 2021approved
EMAMar 2018authorised
CDSCOAug 2018permitted
EDEAug 2021registered
Status by market
FDA
United States · Semglee
US Food and Drug AdministrationApprovedBrand
Semglee
Holder or applicant
Biocon Biologics Inc.
Pathway
351(k)
Approved
Jul 2021
Application or permission
761201
Licence type
351(k) interchangeable, designated Jul 2021
Presentations
100 U/mL, 3 mL pen and 10 mL vial
Note
First interchangeable biosimilar in the United States.
Source
S001, S016
EMA
European Union · Semglee
European Medicines Agency and European CommissionApprovedBrand
Semglee
Holder or applicant
Biosimilar Collaborations Ireland Limited
Pathway
Centralised (Article 10(4))
Approved
Mar 2018
Application or permission
EMEA/H/C/004280
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 2 years
Presentations
see SmPC
Source
S017
CDSCO
India
Central Drugs Standard Control OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Biocon Limited
Pathway
Import and marketing permission
Approved
Aug 2018
Application or permission
Import permission; bulk permission 5 September 2018
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 2 years
Presentations
100 IU/mL cartridge
Note
Product manufactured at Biocon's Malaysian site.
Source
S013
EDE
United Arab Emirates · Semglee
Emirates Drug EstablishmentRegisteredBrand
Semglee
Holder or applicant
Biocon Sdn. Bhd., Malaysia · UAE supplier Alphamed Drug Store
Pathway
Registered medical product
Registered
Aug 2021
Presentations
100 U/mL
Source
S018
Chronology
- EMAMar 2018Authorised by the European Commission as Semglee
- CDSCOAug 2018CDSCO permission granted
- FDAJul 2021Approved by FDA as Semglee
- EDEAug 2021Registered in the UAE as Semglee
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)S018UAE Emirates Drug Establishment, registered medical product directory 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.