Herwenda
Trastuzumab biosimilar developed by EirGenix, development code EG12014. Reference product Herceptin.
Brands by market: Herwenda (EU) · Commercial partner or holder: Sandoz (EU) · Company profile
FDANot listed
EMANov 2023authorised
MHRANot listed
PMDANot listed
HCNot listed
CDSCONot listed
EDENot listed
Approved or registered in 1 of 7 markets
Connections
About Herwenda
Herwenda is a trastuzumab developed by EirGenix in Taiwan and sold in Europe by Sandoz, approved in late 2023. It gave Sandoz a trastuzumab to sit alongside its rituximab, bevacizumab and pegfilgrastim biosimilars in European hospital tenders. It has not been filed in the United States.
Status by market
FDA
United States
Not listed by FDA.
EMA
European Union · Herwenda
European Medicines Agency and European CommissionApprovedBrand
Herwenda
Holder or applicant
Sandoz GmbH
Pathway
Centralised (Article 10(4))
Approved
Nov 2023
Application or permission
EMEA/H/C/005769
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Source
S017 (EMA) · checked Sep 2026
MHRA
United Kingdom
Not listed by MHRA.
PMDA
Japan
Not listed by PMDA.
HC
Canada
Not listed by HC.
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Other developers in the same markets
Where Herwenda holds an approval, these are the other trastuzumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| EMA | 7 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Pfizer (Trazimera), Samsung Bioepis (Ontruzant), Shanghai Henlius Biotech (Hercessi / Zercepac) |
Chronology
- EMANov 2023Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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