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Indian emergency-use tocilizumab

Tocilizumab biosimilar developed by Firm name incomplete in the CDSCO list (Hyderabad). Reference product Actemra (RoActemra in the European Union).

Brands by market: Brand not published by CDSCO (India) · Commercial partner or holder: As listed
FDANot listed
EMANot listed
MHRANot listed
PMDANot listed
HCNot listed
CDSCOOct 2021permitted
EDENot listed
Approved or registered in 1 of 7 markets

About Indian emergency-use tocilizumab

An Indian company received a restricted emergency permission for its tocilizumab in October 2021, for use in COVID-19, at a time when the original product was in short supply. The published Indian list truncates the company's name, so the product is listed as it appears there. No routine permission for arthritis has followed in the published lists.

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
Biopharma Limited, Hyderabad (name as printed in the CDSCO list)
Pathway
Similar Biologic, manufacture and marketing permission
Approved
Oct 2021
Application or permission
MF/BIO/21/000104; drug substance MF/BULK/BD/259/2021 (September 2021)
Indications as licensed
Restricted emergency use in COVID-19
Presentations
80 mg/4 mL, 200 mg/10 mL, 400 mg/20 mL vials (20 mg/mL)
Remarks
Restricted emergency-use permission; not a routine marketing permission.
Source
S011 (CDSCO) · checked Sep 2026
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All tocilizumab biosimilars

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Data current to September 2026.