Lantus sanofi-aventis Deutschland GmbH · Authorised · authorised 9 Jun 2000 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged two years and above
Active substance
Insulin glargine
- SFDA 15
- US FDA 5
- EMA 6
- Health Canada 8
- US price lines 4
- NHS prices 5
- WHO EML 1
- Safety 10
SFDA Saudi Arabia — SFDA human drug list
| Trade name | Strength | Form · route | Pack | Public price | Type | Company | Status |
|---|---|---|---|---|---|---|---|
| BASAGLAR 100 u/ml solution for injection in Pre-Filled pen | 100 IU/ml | Solution for injection in pre-filled pen · Subcutaneous use | 5 Pre-filled pen | SAR 163.20 | Biological · Prescription | ELI LILLY NEDERLAND B.V. | Valid |
| BASALOG ONE | 100 IU/ml | Solution for injection · Subcutaneous use | 1 Pre-filled pen | SAR 38.35 | Biological · Prescription | Biocon Limited | Valid |
| BASALOG ONE | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 191.75 | Biological · Prescription | Biocon Limited | Valid |
| BASALOG ONE | 100 IU/ml | Solution for injection · Subcutaneous use | 3 Pre-filled pen | SAR 115.05 | Biological · Prescription | Biocon Limited | Valid |
| Basaglar Tempo Pen | 100 IU/ml | Solution for injection in pre-filled pen · Subcutaneous use | 5 Pre-filled pen | SAR 191.75 | Biological · Prescription | Eli Lilly Nederland B.V | Valid |
| LANTUS 100 I.U - ML VIAL | 100 IU/ml | Solution · Subcutaneous use | 1 Vial | SAR 220.10 | Biological · Prescription | sanofi-aventis | Valid |
| LANTUS SOLOSTAR 100I.U-ML DISPOSABLE PEN | 100 IU/ml | Solution · Subcutaneous use | 5 Pre-filled pen | SAR 296.45 | Biological · Prescription | sanofi-aventis | Valid |
| TOUJEO 300 IU/ml Solution for Injection in Pre-filled Pen | 300 IU/ml | Solution for injection in pre-filled pen · Subcutaneous use | 3 Pre-filled pen | SAR 216.95 | Biological · Prescription | sanofi-aventis | Valid |
| TOUJEO 300 IU/ml Solution for Injection in Pre-filled Pen | 300 IU/ml | Solution for injection in pre-filled pen · Subcutaneous use | 5 Pre-filled pen | SAR 356.35 | Biological · Prescription | sanofi-aventis | Valid |
| VIVARO 100 IU/ml pre-filled pen, disposable | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 216.60 | Biological · Prescription | SAJA-SAUDI ARABIAN JAPANESE PHARMACEUTICAL CO | Valid |
| semglee | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 163.05 | Biological · Prescription | Biosimilar Collaborations Ireland Limited (BCIL) | Valid |
| BASAGLAR 100 u/ml Solution For Injection In Pre-Filled Pen | 100 IU/ml | Solution for injection · Subcutaneous use | 5 Pre-filled pen | SAR 202.35 | Biological · Prescription | ELI LILLY REGIONAL OPERATIONS GMBH | Withdrawn by MAH · Not Marketed |
| BASAGLAR 100 u/ml Solution For Injection In Pre-Filled Pen | 100 IU/ml | Solution for injection in pre-filled pen · Subcutaneous use | 5 Pre-filled pen | SAR 191.75 | Biological · Prescription | Eli Lilly Nederland B.V | Withdrawn by MAH · Not Marketed |
| BASAGLAR 100 u/ml Solution For Injection In cartridge | 100 IU/ml | Solution for injection in cartridge · Subcutaneous use | 5 Cartridge | SAR 202.35 | Biological · Prescription | ELI LILLY REGIONAL OPERATIONS GMBH | Withdrawn by MAH · Not Marketed |
| LANTUS 100 I.U - ML CARTRIDGE | 100 IU/ml | Solution · Subcutaneous use | 3 Cartridge | SAR 315.75 | Biological · Prescription | sanofi-aventis | Withdrawn by MAH · Not Marketed |
Indications — CHI Daman Drug Formulary
DIABETES MELLITUS TYPE 1; DIABETES MELLITUS TYPE 2
US FDA United States — FDA approvals (Drugs@FDA)
| Product | Strength | Form · route | Applicant | Status | First approved |
|---|---|---|---|---|---|
| BASAGLAR | 300 UNITS/3ML (100 UNITS/ML) | solution · subcutaneous | ELI LILLY AND CO | Prescription | 16 Dec 2015 |
| SEMGLEE | 100 UNITS/ML | injectable · injection | MYLAN PHARMS INC | Prescription | 11 Jun 2020 |
| SEMGLEE | 10ML(100UNITS/ML); 3ML(100UNITS/ML) | injectable · injection | MYLAN PHARMS INC | Prescription | 28 Jul 2021 |
| REZVOGLAR | 3ML(100UNITS/ML) | injectable · injection | ELI LILLY CO | Prescription | 17 Dec 2021 |
| LANGLARA | 100UNITS/ML | injectable · subcutaneous | SUNSHINE LAKE PHARMA CO LTD | Prescription | 29 Apr 2026 |
EMA European Union — centrally authorised medicines
Toujeo (previously Optisulin) Sanofi-aventis Deutschland GmbH · Authorised · authorised 26 Jun 2000 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children from the age of 6 years.
Abasaglar (previously Abasria) Eli Lilly Nederland B.V. · Authorised · authorised 9 Sep 2014 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Semglee Biosimilar Collaborations Ireland Limited · Authorised · authorised 23 Mar 2018 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Ondibta Sandoz GmbH · Authorised · authorised 9 Jan 2026 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Lusduna Merck Sharp & Dohme B.V. · Withdrawn · authorised 3 Jan 2017 · ATC A10AE04
Therapeutic indication (EMA)
Treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above.
Canada Canada — marketed products (Health Canada)
| Brand | DIN | Strength | Form · route | Company |
|---|---|---|---|---|
| BASAGLAR | 02444844 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | ELI LILLY CANADA INC |
| BASAGLAR | 02461528 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | ELI LILLY CANADA INC |
| LANTUS | 02245689 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| LANTUS | 02251930 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| LANTUS | 02294338 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| SEMGLEE | 02526441 | 100 UNIT / ML | SOLUTION · SUBCUTANEOUS | BIOCON SDN.BHD |
| TOUJEO DOUBLESTAR | 02493373 | 300 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
| TOUJEO SOLOSTAR | 02441829 | 300 UNIT / ML | SOLUTION · SUBCUTANEOUS | SANOFI-AVENTIS CANADA INC |
Prices — United States and England
| Source | Product as listed | Price | Unit / pack | Date |
|---|---|---|---|---|
| US NADAC | BASAGLAR 100 UNIT/ML KWIKPEN | $20.93507 | per ML | 23 Sep 2026 |
| US NADAC | REZVOGLAR 100 UNIT/ML KWIKPEN | $5.92161 | per ML | 23 Sep 2026 |
| US NADAC | SEMGLEE (YFGN) 100 UNIT/ML PEN | $25.75456 | per ML | 23 Sep 2026 |
| US NADAC | SEMGLEE (YFGN) 100 UNIT/ML VL | $26.0674 | per ML | 23 Sep 2026 |
| NHS Drug Tariff | Insulin glargine 100units/ml solution for injection 10ml vials | £25.69 | 1 vial | 1 Oct 2026 |
| NHS Drug Tariff | Insulin glargine 100units/ml solution for injection 3ml cartridges | £34.75 | 5 cartridge | 1 Oct 2026 |
| NHS Drug Tariff | Insulin glargine 100units/ml solution for injection 3ml pre-filled disposable devices | £34.75 | 5 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Insulin glargine 300units/ml solution for injection 1.5ml pre-filled disposable devices | £32.14 | 3 pre-filled disposable injection | 1 Oct 2026 |
| NHS Drug Tariff | Insulin glargine 300units/ml solution for injection 3ml pre-filled disposable devices | £64.27 | 3 pre-filled disposable injection | 1 Oct 2026 |
NADAC: average price US retail pharmacies pay to buy the medicine. NHS Drug Tariff Part VIIIA: basic price reimbursed to pharmacies in England and Wales.
WHO WHO Model List of Essential Medicines (2025)
- 18.5.1. Insulins · core
Therapeutic equivalent to insulin (analogue, long-acting) for Type 2 diabetes mellitus; Therapeutic equivalent to insulin (analogue, long-acting) for Type 1 diabetes mellitus
Safety signals and safety-related labeling changes
- US FDA 12 Mar 2026 SOLIQUA 100/33 — safety-related labeling change
Labeling sections changed: Contraindications; Warnings and Precautions; Adverse Reactions; Drug Interactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 9 Aug 2024 REZVOGLAR — safety-related labeling change
Labeling sections changed: Adverse Reactions - US FDA 29 Nov 2023 SEMGLEE — safety-related labeling change
Labeling sections changed: Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - US FDA 20 Jul 2021 BASAGLAR — safety-related labeling change
Labeling sections changed: Warnings and Precautions; Adverse Reactions; Use in Specific Populations; Patient Counseling Information / Patient Information / Medication Guide - EMA PRAC 17 Apr 2020 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: Yes - EMA PRAC 28 Nov 2019 PRAC signal: Cutaneous amyloidosis
Action for MAH: update of the product information: No - EMA PRAC 30 Nov 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: Yes - EMA PRAC 29 Sep 2017 PRAC signal: Potential increased risk of medication error associated with withdrawing insulin from pre-filled pens and cartridges, leading to dysglycaemia
Action for MAH: update of the product information: No - EMA PRAC 5 May 2017 PRAC signal: Potential increased risk of medication error associated with pre-filled pens and cartridges presentations, leading to inadequate diabetes control
Action for MAH: update of the product information: Yes - MHRA 11 Dec 2014 Insulin glargine: studies of possible cancer link
The European Medicines Agency has advised that no change in recommendations for use is required at present.
Combinations containing Insulin glargine
Values as published by each source: SFDA human drug list (4-2026, as published by the Council of Health Insurance; indications from the CHI Daman Drug Formulary), Drugs@FDA, EMA medicines data, Health Canada Drug Product Database (Open Government Licence – Canada), CMS NADAC, NHS Drug Tariff Part VIIIA (NHSBSA Copyright, Open Government Licence v3.0), WHO Model List of Essential Medicines (CC BY 3.0 IGO; regrouped by active substance, not created by WHO), EMA PRAC, US FDA safety-related labeling changes and MHRA Drug Safety Update (Open Government Licence v3.0). Sources and reuse. Not a substitute for the official registers or the product information.