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Genesys insulin glargine

Insulin glargine biosimilar developed by Genesys Biologics. Reference product Lantus.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Genesys Biologics · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCODec 2025permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
Insulin glarginemoleculeGenesys Biologicsdeveloper1 of 7markets0trials behind it0other products, same developer9rival developers in its markets

About Genesys insulin glargine

Genesys Biologics received its Indian manufacturing permission for insulin glargine in December 2025, in cartridges, with a separate permission for the drug substance. It is among the most recent Indian entrants.

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

MHRA

United Kingdom

Not listed by MHRA.

PMDA

Japan

Not listed by PMDA.

HC

Canada

Not listed by HC.

CDSCO

India

Central Drugs Standard Control OrganisationApproved
Brand
Not published by CDSCO (INN only)
Holder or applicant
Genesys Biologics Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Dec 2025
Application or permission
MF/BIO/25/000186; drug substance MF/BIO/25/000187
Indications as licensed
Type 2 diabetes in adults
Presentations
100 IU/mL, 3 mL cartridge
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

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

MarketRivalsDevelopers (product)
CDSCO9Biocon Biologics (Semglee), Cipla (Cipla insulin glargine), Eli Lilly (Rezvoglar / Abasaglar), Eris Lifesciences (Eris insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), M.J. Biopharm (M.J. Biopharm insulin glargine), Regenix (Regenix insulin glargine), Wockhardt (Wockhardt insulin glargine)

Chronology

Sources

All insulin glargine biosimilars

Planning insulin glargine biosimilar development?

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Data current to September 2026.