Ontruzant
Trastuzumab biosimilar developed by Samsung Bioepis, development code SB3. Reference product Herceptin.
Brands by market: Ontruzant (USA, EU) · Commercial partner or holder: Organon (USA)
FDAJan 2019approved
EMANov 2017authorised
CDSCOnot listed
EDEnot listed
Status by market
FDA
United States · Ontruzant
US Food and Drug AdministrationApprovedBrand
Ontruzant
Holder or applicant
Samsung Bioepis Co., Ltd.
Pathway
351(k)
Approved
Jan 2019
Application or permission
761100
Licence type
351(k) biosimilar, not interchangeable
Presentations
150 mg, 420 mg vials
Source
S001, S016
EMA
European Union · Ontruzant
European Medicines Agency and European CommissionApprovedBrand
Ontruzant
Holder or applicant
Samsung Bioepis NL B.V.
Pathway
Centralised (Article 10(4))
Approved
Nov 2017
Application or permission
EMEA/H/C/004323
Indications as licensed
Early and metastatic breast cancer, metastatic gastric cancer
Presentations
see SmPC
Note
First EU trastuzumab biosimilar.
Source
S017
CDSCO
India
Not listed by CDSCO.
EDE
United Arab Emirates
Not listed by EDE.
Chronology
- EMANov 2017Authorised by the European Commission as Ontruzant
- FDAJan 2019Approved by FDA as Ontruzant
Sources
S001FDA, Biosimilar Product Information (approved biosimilars table) Primary (regulator)S016FDA Purple Book, monthly data downloads January to August 2026 Primary (regulator)S017EMA, medicines data table (medicines-output-medicines-report_en.xlsx) Primary (regulator)
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