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Shilpa Biologicals adalimumab

Adalimumab biosimilar developed by Shilpa Biologicals. Reference product Humira.

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: Shilpa Biologicals · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOJun 2023permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Shilpa Biologicals adalimumab

Shilpa Biologicals received its adalimumab permission in 2023, for the high-concentration form, and added psoriasis, hidradenitis suppurativa and bowel disease in 2025. Shilpa is a newer entrant in Indian biosimilars, better known for its cancer generics, and adalimumab is one of its first biologics.

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
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 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Shilpa Biologicals adalimumab holds an approval, these are the other adalimumab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO4Enzene Biosciences (Enzene Biosciences adalimumab), Hetero (Mabura), Reliance Life Sciences (Reliance Life Sciences adalimumab), Zydus Lifesciences (Exemptia / Cadalimab)

Chronology

Sources

All adalimumab biosimilars

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Data current to September 2026.