Herwenda
Trastuzumab biosimilar developed by EirGenix, development code EG12014. Reference product Herceptin.
Brands by market: Herwenda (EU) · Commercial partner or holder: Sandoz (EU)
FDAnot listed
EMANov 2023authorised
CDSCOnot listed
EDEnot listed
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
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMANov 2023Authorised by the European Commission
Sources
S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
Planning trastuzumab biosimilar development?
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