Shilpa Biologicals adalimumab
Adalimumab biosimilar developed by Shilpa Biologicals. Reference product Humira.
Brands by market: Brand not published by CDSCO (India) ยท Commercial partner or holder: Shilpa Biologicals
FDAnot listed
EMAnot listed
CDSCOJun 2023permitted
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
Shilpa Biologicals Pvt Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Jun 2023
Application or permission
MF/BIO/23/000057; bulk MF/BIO/23/000078; additional indications MF/BIO/25/000005
Indications as licensed
RA at permission; psoriasis, HS, Crohn's disease, UC added January 2025
Presentations
40/0.4 PFS (100 mg/mL)
Source
S011
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- CDSCOJun 2023CDSCO permission granted
Sources
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