Ontruzant
Trastuzumab biosimilar developed by Samsung Bioepis, development code SB3. Reference product Herceptin.
About Ontruzant
Ontruzant was the first trastuzumab biosimilar approved in Europe, in November 2017. It was developed by Samsung Bioepis and is sold in the United States by Organon, where it was approved in 2019, and in Canada from 2022. It is not registered in the UAE or Japan. Samsung Bioepis built its early portfolio around cancer and immunology antibodies, and Ontruzant was its first oncology product.
Status by market
United States · Ontruzant
US Food and Drug AdministrationApprovedEuropean Union · Ontruzant
European Medicines Agency and European CommissionApprovedUnited Kingdom · Ontruzant
Medicines and Healthcare products Regulatory AgencyApprovedJapan
Not listed by PMDA.
Canada · Ontruzant
Health CanadaApprovedIndia
Not listed by CDSCO.
United Arab Emirates
Not listed by EDE.
Trials behind this product
Comparative trials on ClinicalTrials.gov matched to Ontruzant 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 |
|---|---|---|---|---|---|---|---|---|
| SB3 | Samsung Bioepis | Herceptin | Phase 3 | Comparative efficacy | Completed | Apr 2014 | Mar 2016 | NCT02149524 |
Other developers in the same markets
Where Ontruzant holds an approval, these are the other trastuzumab biosimilars approved in that market.
| Market | Rivals | Developers (product) |
|---|---|---|
| FDA | 5 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| EMA | 7 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), EirGenix (Herwenda), Pfizer (Trazimera), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| MHRA | 5 | Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), CuraTeQ Biologics (Dazublys / CuraTeQ trastuzumab), Pfizer (Trazimera), Shanghai Henlius Biotech (Hercessi / Zercepac) |
| HC | 4 | Amgen (Kanjinti), Biocon Biologics (Ogivri / CANMAb), Celltrion (Herzuma), Pfizer (Trazimera) |
Same developer, other molecules
Other biosimilars in the Atlas developed by Samsung Bioepis: Aybintio, Byooviz, Epysqli, Eticovo / Benepali, Hadlima / Imraldi, Opuviz, Ospomyv / Xbryk / Obodence, Pyzchiva, Renflexis / Flixabi.
Chronology
- EMANov 2017Authorised by the European Commission as Ontruzant
- FDAJan 2019Approved by FDA as Ontruzant
- HCJan 2022Notice of Compliance, Health Canada 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)S022Health Canada, Drug Product Database data extract (active and inactive product files, biosimilar table) Primary (regulator)S023MHRA Products, substance lists of licensed medicines (products.mhra.gov.uk) Primary (regulator)
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