Merilog / Insulin aspart Sanofi
Insulin aspart biosimilar developed by Sanofi, development code SAR341402. Reference product NovoRapid (NovoLog in the United States).
Brands by market: Merilog (USA); Insulin aspart Sanofi (EU); Truvelog Mix 30 (EU, withdrawn); biphasic import (India) · Commercial partner or holder: Sanofi · Company profile
FDAFeb 2025approved
EMAJun 2020authorised
MHRALicenseddate not shown
PMDAMar 2021approved
HCOct 2020approved
CDSCOMay 2023permitted
EDENot listed
Approved or registered in 6 of 7 markets
Connections
About Merilog / Insulin aspart Sanofi
Sanofi's insulin aspart was the first insulin aspart biosimilar in Europe, in 2020, and in Canada, as Trurapi, the same year. Japan approved it in 2021. In the United States it was approved as Merilog in February 2025, the first fast-acting insulin biosimilar there. A European premixed version, Truvelog Mix 30, was approved in 2022 and withdrawn in 2024, though Sanofi imports the premix into India.
Status by market
FDA
United States · Merilog
US Food and Drug AdministrationApprovedBrand
Merilog
Holder or applicant
Sanofi-Aventis U.S. LLC
Pathway
351(k)
Approved
Feb 2025
Application or permission
761325
Licence type
351(k) biosimilar, not interchangeable
Reference product in the Purple Book
Novolog
Marketing status (Purple Book)
Prescription, marketed
Presentations
100 units/mL, 3 mL pen and 10 mL vial
Remarks
First FDA-approved rapid-acting insulin biosimilar.
Source
S001 (FDA); S016 (FDA Purple Book) · checked Sep 2026
EMA
European Union · Insulin aspart Sanofi
European Medicines Agency and European CommissionApprovedBrand
Insulin aspart Sanofi
Holder or applicant
Sanofi Winthrop Industrie
Pathway
Centralised (Article 10(4))
Approved
Jun 2020
Application or permission
EMEA/H/C/005033
Indications as licensed
Diabetes mellitus in adults, adolescents and children from 1 year
Presentations
see SmPC
Remarks
First EU insulin aspart biosimilar.
Source
S017 (EMA) · checked Sep 2026
EMA
European Union · Truvelog Mix 30
European Medicines Agency and European CommissionWithdrawnBrand
Truvelog Mix 30
Holder or applicant
Sanofi Winthrop Industrie
Pathway
Centralised (Article 10(4))
Approved
Apr 2022
Application or permission
EMEA/H/C/005635
Withdrawn
Jan 2024
Presentations
see SmPC
Remarks
Biphasic 30/70 premix.
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom · Trurapi
Medicines and Healthcare products Regulatory AgencyApprovedBrand
Trurapi
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 cartridge, pen and vial
Source
S023 (MHRA Products) · checked Sep 2026
PMDA
Japan · Insulin Aspart BS NR Sanofi
Pharmaceuticals and Medical Devices Agency and MHLWApprovedBrand
Insulin Aspart BS NR Sanofi
Holder or applicant
Sanofi K.K.
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2021
Indications as licensed
Diabetes mellitus requiring insulin
Presentations
SoloStar pen, cartridge, 100 IU/mL vial
Remarks
Insulin Aspart Biosimilar 1, the first in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC
Canada · Trurapi
Health CanadaApprovedBrand
Trurapi
Holder or applicant
Sanofi-aventis Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Oct 2020
Application or permission
DIN 02506564, 02506572, 02529254
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
Sanofi India Limited
Pathway
Import and marketing permission
Approved
May 2023
Application or permission
IMP/BIO/23/000058
Indications as licensed
Diabetes mellitus
Presentations
Biphasic 30/70, 100 IU/mL
Remarks
Biphasic premix import.
Source
S012 (CDSCO) · checked Sep 2026
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Merilog / Insulin aspart Sanofi holds an approval, these are the other insulin aspart biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 2 | Biocon Biologics (Kirsty), Not stated in the Purple Book (Garzulys) |
| EMA | 2 | Biocon Biologics (Kirsty), Gan & Lee Pharmaceuticals (Dazparda) |
| MHRA | 1 | Biocon Biologics (Kirsty) |
| HC | 1 | Biocon Biologics (Kirsty) |
| CDSCO | 1 | Biogenomics (Biogenomics insulin aspart) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Sanofi: Insulin lispro Sanofi, Shantha human insulin.
Chronology
- EMAJun 2020Authorised by the European Commission as Insulin aspart Sanofi
- HCOct 2020Notice of Compliance, Health Canada as Trurapi
- PMDAMar 2021Approved by MHLW as Insulin Aspart BS NR Sanofi
- CDSCOMay 2023CDSCO permission granted
- EMAJan 2024Truvelog Mix 30 authorisation withdrawn
- FDAFeb 2025Approved by FDA as Merilog
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)S012CDSCO, new drugs (r-DNA origin) approved for import and marketing, Jan 2020 to June 2026 (CT-18) 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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