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Insulin lispro Sanofi

Insulin lispro biosimilar developed by Sanofi, development code SAR342434. Reference product Humalog.

Brands by market: Insulin lispro Sanofi (EU); Admelog (USA, approved under 505(b)(2), not a 351(k) biosimilar) · Commercial partner or holder: Sanofi · Company profile
FDANot listed
EMAJul 2017authorised
MHRALicenseddate not shown
PMDAMar 2020approved
HCNov 2017approved
CDSCONot listed
EDENot listed
Approved or registered in 4 of 7 markets
Connections
Insulin lispromoleculeSanofideveloper4 of 7markets0trials behind it2other products, same developer1rival developers in its markets

About Insulin lispro Sanofi

Sanofi's insulin lispro was the first insulin lispro biosimilar in Europe, in 2017, and in Canada, as Admelog, the same year. Japan approved it in 2020. In the United States, Admelog was approved in 2017 through the older drug route, before insulins became biologics, so it is a licensed insulin there but not a biosimilar.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Insulin lispro Sanofi

European Medicines Agency and European CommissionApproved
Brand
Insulin lispro Sanofi
Holder or applicant
Sanofi Winthrop Industrie
Pathway
Centralised (Article 10(4))
Approved
Jul 2017
Application or permission
EMEA/H/C/004303
Indications as licensed
Diabetes mellitus in adults and children
Presentations
see SmPC
Remarks
First EU insulin lispro biosimilar.
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom · Admelog

Medicines and Healthcare products Regulatory AgencyApproved
Brand
Admelog
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 Lispro BS HU Sanofi

Pharmaceuticals and Medical Devices Agency and MHLWApproved
Brand
Insulin Lispro BS HU Sanofi
Holder or applicant
Sanofi K.K.
Pathway
Biosimilar (MHLW approval on PMDA review)
Approved
Mar 2020
Indications as licensed
Diabetes mellitus requiring insulin
Presentations
SoloStar pen, cartridge, 100 U/mL vial
Remarks
Insulin Lispro Biosimilar 1, the first in Japan.
Source
S020 (PMDA) · checked Sep 2026
HC

Canada · Admelog

Health CanadaApproved
Brand
Admelog
Holder or applicant
Sanofi-aventis Canada INC
Pathway
Biosimilar biologic drug (Notice of Compliance)
Approved
Nov 2017
Application or permission
DIN 02469898, 02469901, 02469871
Presentations
100 units/mL
Remarks
Also Admelog Solostar.
Source
S022 (Health Canada) · checked Sep 2026
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Insulin lispro Sanofi holds an approval, these are the other insulin lispro biosimilars approved in that market.

MarketRivalsDevelopers (product)
EMA1Gan & Lee Pharmaceuticals (Bysumlog)

Same developer, other molecules

Other biosimilars in the Atlas developed by Sanofi: Merilog / Insulin aspart Sanofi, Shantha human insulin.

Chronology

Sources

All insulin lispro biosimilars

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Data current to September 2026.