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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) ยท Commercial partner or holder: M.J. Biopharm
FDAnot listed
EMAnot listed
CDSCOMar 2024permitted
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union

Not listed by EMA.

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
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All insulin glargine biosimilars

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Data current to September 2026.