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Exemptia / Cadalimab

Adalimumab biosimilar developed by Cadila Healthcare (Zydus Lifesciences), development code ZRC-3197. Reference product Humira.

Brands by market: Exemptia (India); Cadalimab (India, second brand); Adfrar (India, Torrent) · Commercial partner or holder: Zydus Lifesciences; Torrent (Adfrar) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOSep 2014permitted
EDENot listed
Approved or registered in 1 of 7 markets
Connections
AdalimumabmoleculeCadila Healthcaredeveloper1 of 7markets0trials behind it10other products, same developer4rival developers in its markets

About Exemptia / Cadalimab

Exemptia is the first adalimumab biosimilar approved anywhere in the world. Zydus, then Cadila Healthcare, received the Indian permission in September 2014, two years before the first approval in the United States. It has since been sold under a second Zydus brand, Cadalimab, and Torrent markets the same product as Adfrar. It is not approved outside India. It was the first of many Indian biosimilars to be approved before any Western one.

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 · Exemptia

Central Drugs Standard Control OrganisationApproved
Brand
Exemptia
Holder or applicant
Cadila Healthcare Ltd
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Sep 2014
Application or permission
MF-222/2014; BULK-223/2014
Indications as licensed
Rheumatoid arthritis (adult) at permission
Presentations
20 mg and 40 mg PFS (50 mg/mL)
Remarks
First adalimumab biosimilar approved anywhere.
Source
S014 (CDSCO) · checked Sep 2026
CDSCO

India · Adfrar

Central Drugs Standard Control OrganisationUnverified
Brand
Adfrar
Holder or applicant
Torrent Pharmaceuticals
Pathway
Marketed brand
Approved
Unverified
Presentations
20 mg and 40 mg PFS (50 mg/mL)
Source
S006 (GaBI Online); S014 (CDSCO) · checked Sep 2026

Marketed brand; no separate CDSCO permission appears in the published lists.

EDE

United Arab Emirates

Not listed by EDE.

Other developers in the same markets

Where Exemptia / Cadalimab 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), Shilpa Biologicals (Shilpa Biologicals adalimumab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Zydus Lifesciences: Nufymco, Zydus aflibercept, Zydus bevacizumab, Zydus epoetin, Zydus follitropin alfa, Zydus peginterferon alfa-2b, Zydus pertuzumab, Zydus rituximab, Zydus teriparatide, Zydus trastuzumab.

Chronology

Sources

All adalimumab biosimilars

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Data current to September 2026.