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M.J. Biopharm insulin glargine

Insulin glargine biosimilar developed by M.J. Biopharm. Reference product Lantus.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: M.J. Biopharm · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOMar 2024permitted
EDENot listed
Approved or registered in 1 of 7 markets

About M.J. Biopharm insulin glargine

M.J. Biopharm received its Indian manufacturing permission for insulin glargine in 2024, in vials and cartridges, alongside a permission for the drug substance. It is a specialist Indian insulin maker.

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
M.J. Biopharm Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Mar 2024
Application or permission
MF/BIO/24/000037; drug substance MF/BIO/24/000039
Indications as licensed
Type 2 diabetes
Presentations
100 IU/mL, 10 mL vial and 3 mL cartridge
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where M.J. Biopharm 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), Genesys Biologics (Genesys insulin glargine), LG Chem (LG Life Sciences insulin glargine), Lupin (Lupin insulin glargine), Regenix (Regenix insulin glargine), Wockhardt (Wockhardt insulin glargine)

Same developer, other molecules

Other biosimilars in the Atlas developed by M.J. Biopharm: M.J. Biopharm human insulin.

Chronology

Sources

All insulin glargine biosimilars

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Data current to September 2026.