Tuznue / Hervelous
Trastuzumab biosimilar developed by Prestige Biopharma, development code HD201. Reference product Herceptin.
About Tuznue / Hervelous
Prestige Biopharma, based in Singapore, filed its trastuzumab in Europe twice, first as Tuznue and later as Hervelous. Both applications were withdrawn before the committee gave an opinion. The product has no approval in any of the seven markets.
Status by market
United States
Not listed by FDA.
European Union · Tuznue
European Medicines Agency and European CommissionWithdrawnEuropean Union · Hervelous
European Medicines Agency and European CommissionWithdrawnUnited Kingdom
Not listed by MHRA.
Japan
Not listed by PMDA.
Canada
Not listed by HC.
India
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Tuznue / Hervelous by development code, brand or developer. Registry data, sponsor-entered.
| Candidate | Developer or sponsor | Reference product | Phase | Design | Registry status | Started | Primary completion | Registry record |
|---|---|---|---|---|---|---|---|---|
| HD201 | Prestige Biopharma | Herceptin | Phase 3 | Comparative efficacy | Completed | Feb 2018 | Apr 2019 | NCT03013504 |
Chronology
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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