Bysumlog

Insulin lispro biosimilar developed by Gan & Lee Pharmaceuticals. Reference product Humalog.

Brands by market: Bysumlog (EU) · Commercial partner or holder: Gan & Lee Pharmaceuticals Europe (Sandoz) · Company profile
FDANot listed
EMAMay 2026authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets

About Bysumlog

Bysumlog is Gan & Lee's insulin lispro, approved in Europe in May 2026, the second insulin lispro biosimilar there and nine years after the first. It completes Gan & Lee's set of three European insulins with Ondibta and Dazparda.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Bysumlog

European Medicines Agency and European CommissionApproved
Brand
Bysumlog
Holder or applicant
Gan & Lee Pharmaceuticals Europe GmbH
Pathway
Centralised (Article 10(4))
Approved
May 2026
Application or permission
EMEA/H/C/006158
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
EMA1Sanofi (Insulin lispro Sanofi)

Same developer, other molecules

Other biosimilars in the Atlas developed by Gan & Lee Pharmaceuticals: Dazparda, Ondibta.

Chronology

Sources

All insulin lispro biosimilars

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Data current to September 2026.