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Brands by market: Merilog (USA); Insulin aspart Sanofi (EU); Truvelog Mix 30 (EU, withdrawn); biphasic import (India) · Commercial partner or holder: Sanofi
FDAFeb 2025approved
EMAJun 2020authorised
CDSCOMay 2023permitted
EDEnot listed
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
Presentations
100 units/mL, 3 mL pen and 10 mL vial
Note
First FDA-approved rapid-acting insulin biosimilar.
Source
S001, S016
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
Note
First EU insulin aspart biosimilar.
Source
S017
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Withdrawn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
Note
Biphasic 30/70 premix.
Source
S017
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
Note
Biphasic premix import.
Source
S012
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMAJun 2020Authorised by the European Commission as Insulin aspart 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- EMAJan 2024Truvelog Mix 30 authorisation withdrawn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)
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