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 · Company profile
FDAJul 2021approved
EMAMar 2018authorised
MHRALicenseddate not shown
PMDAMar 2016approved
HCApr 2022approved
CDSCOAug 2018permitted
EDEAug 2021registered
Approved or registered in 7 of 7 markets
Connections
About Semglee
Semglee is Biocon's insulin glargine, the first biosimilar of any kind to be designated interchangeable in the United States, in July 2021. It was approved in Europe in 2018, in Canada in 2022, and is registered in the UAE from Biocon's plant in Malaysia. In Japan the same insulin was sold by Fujifilm from 2016. In India, Biocon holds an import permission for the Malaysian product. Originally marketed with Mylan, it now sits with Biocon Biologics.
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
Reference product in the Purple Book
Lantus
Marketing status (Purple Book)
Prescription, marketed
First-interchangeable exclusivity expiry
Nov 2022
Presentations
100 U/mL, 3 mL pen and 10 mL vial
Remarks
First interchangeable biosimilar in the United States.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
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 (EMA) · checked Sep 2026
MHRA
United Kingdom · Semglee
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Semglee
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 pen
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Insulin Glargine BS FFP
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Insulin Glargine BS FFP
Holder or applicant
Fujifilm Pharma (Biocon product)
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2016
Indications as licensed
Diabetes mellitus requiring insulin
Presentations
Kit and 100 units/mL
Remarks
Insulin Glargine Biosimilar 2.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Semglee
Health CanadaApprovedBrand
Semglee
Holder or applicant
Biocon SDN.BHD
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Apr 2022
Application or permission
DIN 02526441
Presentations
100 units/mL
Source
S022 (Health Canada) · checked Sep 2026
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
Remarks
Product manufactured at Biocon's Malaysian site.
Source
S013 (CDSCO) · checked Sep 2026
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 (UAE Emirates Drug Establishment) · checked Sep 2026
Other developers in the same markets
Where Semglee holds an approval, these are the other insulin glargine biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 2 | Eli Lilly (Rezvoglar / Abasaglar), Sunshine Lake Pharma (Langlara) |
| EMA | 2 | Eli Lilly (Rezvoglar / Abasaglar), Gan & Lee Pharmaceuticals (Ondibta) |
| MHRA | 1 | Eli Lilly (Rezvoglar / Abasaglar) |
| PMDA | 1 | Eli Lilly (Rezvoglar / Abasaglar) |
| HC | 1 | Eli Lilly (Rezvoglar / Abasaglar) |
| CDSCO | 9 | Cipla (Cipla insulin glargine), Eli Lilly (Rezvoglar / Abasaglar), 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) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Biocon Biologics: Biocon human insulin, Bosaya / Aukelso / Vevzuo / Evfraxy, Fulphila / Vivlipeg / Biopegfil, Jobevne / Abevmy / Krabeva, Kirsty, Ogivri / CANMAb, Yesafili, Yesintek / Usrenty.
Chronology
- PMDAMar 2016Approved by MHLW as Insulin Glargine BS FFP
- 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
- HCApr 2022Notice of Compliance, Health Canada 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)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)
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