# Trastuzumab biosimilars

Source: https://onco.cc/drugs/trastuzumab-biosimilars/  
OnCo record `trastuzumab-biosimilars` (Treatment). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

Near-identical copies of Herceptin, approved since 2017, that cut the price of HER2 treatment and widened access worldwide.

## Summary

Six US-approved biosimilars (first: Ogivri, December 2017) with equivalence shown on pCR or ORR endpoints; WHO prequalification (2019) enabled low- and middle-income access. Biosimilar uptake exceeds 80% of trastuzumab volume in the US and EU; they are the trastuzumab component of many chemotherapy-antibody regimens and control arms.

## Fields

- Kind: Treatment
- Status: approved
- Last checked: 2026-09-07
- Brand: Ogivri, Herzuma, Kanjinti, Trazimera, Ontruzant, Hercessi
- Modality: Biosimilar monoclonal antibody (anti-HER2)
- Mechanism: Same amino acid sequence and mechanism as trastuzumab; analytical and clinical equivalence demonstrated.
- Approvals: US 2017: First trastuzumab biosimilar (Ogivri); all trastuzumab indications; EU 2017: Ontruzant, first EU trastuzumab biosimilar

## Sources

- Wikipedia: https://en.wikipedia.org/wiki/Biosimilar
- FDA label (DailyMed): https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Trastuzumab%20biosimilars

## Connected records

- cancers: [Gastric & gastro-oesophageal junction cancer](https://onco.cc/cancers/gastric/), [HER2-positive breast cancer](https://onco.cc/cancers/breast-her2-positive/)
- technologies: [Monoclonal antibodies](https://onco.cc/technologies/monoclonal-antibody/)
- targets: [HER2](https://onco.cc/targets/her2/)
- companies: [Biocon](https://onco.cc/companies/biocon/), [Biocon Biologics](https://onco.cc/companies/biocon-biologics/), [Organon & Co.](https://onco.cc/companies/organon/), [Shanghai Henlius Biotech](https://onco.cc/companies/henlius/), [Viatris](https://onco.cc/companies/viatris/)
- terms: [Biologics Price Competition and Innovation Act 2010](https://onco.cc/terms/bpcia/), [Biosimilar](https://onco.cc/terms/biosimilar/)
- trials: [Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer](https://onco.cc/trials/nct01275677/), [Docetaxel, Carboplatin, Trastuzumab, and Pertuzumab With or Without Estrogen Deprivation in Treating Patients With Hormone Receptor-Positive, HER2-Positive Operable or Locally Advanced Breast Cancer](https://onco.cc/trials/nct02003209/), [MARGetuximab Or Trastuzumab (MARGOT)](https://onco.cc/trials/nct04425018/), [Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy](https://onco.cc/trials/nct00769379/)
- people: [Kiran Mazumdar-Shaw](https://onco.cc/people/mazumdar-shaw-kiran/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Prices and value](https://onco.cc/bottlenecks/b-drug-pricing/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)
- ideas: [Make the biosimilar the default at the pharmacy for trastuzumab, bevacizumab and rituximab](https://onco.cc/ideas/idea-cost-biosimilar-default-substitution/)
- roadmaps: [Global access and affordability roadmap: essential medicines and generics → biosimilars and frugal trials → reliance, pooling and homegrown innovation](https://onco.cc/roadmaps/global-access-roadmap/)

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