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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) ยท Commercial partner or holder: As listed
FDAnot listed
EMAnot listed
CDSCOOct 2021permitted
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 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)
Note
Restricted emergency-use permission; not a routine marketing permission.
Source
S011
EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All tocilizumab biosimilars

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Data current to September 2026.