Home/Biosimilar Atlas/Trastuzumab/Tuznue / Hervelous

Tuznue / Hervelous

Trastuzumab biosimilar developed by Prestige Biopharma, development code HD201. Reference product Herceptin.

Brands by market: Tuznue and Hervelous (EU, applications withdrawn) · Commercial partner or holder: Prestige Biopharma
FDAnot listed
EMAwithdrawn
CDSCOnot listed
EDEnot listed

Status by market

FDA

United States

Not listed by FDA.

EMA

European Union · Tuznue

European Medicines Agency and European CommissionWithdrawn
Brand
Tuznue
Holder or applicant
Prestige Biopharma Belgium
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/005066
Withdrawn
date not published
Presentations
see SmPC
Note
Application withdrawn before opinion.
Source
S017
EMA

European Union · Hervelous

European Medicines Agency and European CommissionWithdrawn
Brand
Hervelous
Holder or applicant
Prestige Biopharma Belgium
Pathway
Centralised (Article 10(4))
Approved
not published
Application or permission
EMEA/H/C/005880
Withdrawn
date not published
Presentations
see SmPC
Note
Application withdrawn before opinion.
Source
S017
CDSCO

India

Not listed by CDSCO.

EDE

United Arab Emirates

Not listed by EDE.

Chronology

Sources

All trastuzumab biosimilars

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Data current to September 2026.