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Biocad infliximab

Infliximab biosimilar developed by Biocad, development code BCD-055. Reference product Remicade.

Brands by market: Brand not published by CDSCO (India, import) · Commercial partner or holder: Biocad India (import) · Company profile
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCODec 2019permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Biocad infliximab

Biocad, the Russian developer, has held an Indian import permission for its infliximab since the end of 2019, covering the full range of arthritis, bowel and skin uses.

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
Biocad India Pvt Ltd
Pathway
Import and marketing permission
Approved
Dec 2019
Application or permission
Import permission
Indications as licensed
RA, PsA, AS, psoriasis, Crohn's disease, UC
Presentations
100 mg lyophilised vial
Source
S013 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Trials behind this product

Comparative trials on ClinicalTrials.gov matched to Biocad infliximab by development code, brand or developer. Registry data, sponsor-entered.

CandidateDeveloper or sponsorReference productPhaseDesignRegistry statusStartedPrimary completionRegistry record
BCD-055BiocadRemicadePhase 3Comparative efficacyCompletedJan 2016May 2017NCT02762812
BCD-055BiocadRemicadePhase 3Comparative efficacyCompletedJan 2016Jul 2018NCT02762838

Other developers in the same markets

Where Biocad infliximab holds an approval, these are the other infliximab biosimilars approved in that market.

MarketRivalsDevelopers (product)
CDSCO2Celltrion (Remsima / Inflectra), Reliance Life Sciences (Reliance Life Sciences infliximab)

Same developer, other molecules

Other biosimilars in the Atlas developed by Biocad: Biocad rituximab, Biocad trastuzumab.

Chronology

Sources

All infliximab biosimilars

Planning infliximab biosimilar development?

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Data current to September 2026.