Enzene Biosciences adalimumab
Adalimumab biosimilar developed by Enzene Biosciences (Alkem). Reference product Humira.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Enzene Biosciences
FDAnot listed
EMAnot listed
CDSCOOct 2022permitted
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 OrganisationApprovedBrand
Not published by CDSCO (INN only)
Holder or applicant
Enzene Biosciences Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2022
Application or permission
MF/BIO/22/000100; additional indications MF/BIO/24/000046
Indications as licensed
Ankylosing spondylitis at permission; RA, PsA, HS, Crohn's disease, UC, psoriasis, JIA added April 2024
Presentations
40/0.4 (100 mg/mL, 2022); 20/0.2, 40/0.4, 80/0.8 (2024)
Note
India's first 100 mg/mL adalimumab.
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOOct 2022CDSCO permission granted
Sources
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