Trastuzumab is a Monoclonal Antibody owned by F. Hoffmann-La Roche, and is involved in 242 clinical trials, of which 194 were completed, 46 are ongoing, and 2 are planned.

Trastuzumab is cytotoxic to cells expressing human epidermal growth factor receptor 2. The drug inhibits the proliferation of human tumor cells that overexpress HER2. The drug acts as mediator of antibody-dependent cellular cytotoxicity. Trastuzumab binds to the HER2 (c-erbB2) proto-oncogene, an EGF receptor-like protein found in breast cancer cells. The binding leads to antibody mediated (complement mediated) killing of the HER2 positive cells.

The revenue for Trastuzumab is expected to reach a total of $14.9bn through 2038. This change impacts the valuation of this asset and is an important factor to understand the current value of the drug in a clinical process. View the complete picture with the Trastuzumab NPV Report.

Trastuzumab was originated by Genentech USA and is currently owned by F. Hoffmann-La Roche.

Trastuzumab Overview

Trastuzumab (Herceptin, Herclon) is a humanized IgG1 kappa monoclonal antibody. It is formulated as freeze-dried powder for solution for intravenous administration and solution for subcutaneous, intravenous route of administration. Herceptin is indicated for the treatment of adult patients with HER2 positive metastatic breast cancer, in combination with paclitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable, in combination with docetaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease, adult patients with HER2 positive early breast cancer, in combination with capecitabine or 5-fluorouracil and cisplatin is indicated for the treatment of adult patients with HER2 positive metastatic adenocarcinoma of the stomach or gastro-esophageal junction who have not received prior anti-cancer treatment for their metastatic disease. Trastuzumab is produced by recombinant DNA technology in a mammalian cell (Chinese Hamster Ovary) culture containing the antibiotic gentamicin. The drug candidate is based on enhanze technology which is a drug delivery platform designed to increase the absorption and dispersion of biologics.

The drug candidate is under development for the treatment of non-squamous non-small cell lung cancer. It is administered through intravenous route. It was also investigated for intravenous urothelial cancer and adjuvant HER2 positive breast cancer, ductal carcinoma in situ and pancreatic cancer.

F. Hoffmann-La Roche Overview

F. Hoffmann-La Roche (Roche) is a biotechnology company that develops drugs and diagnostics to treat major diseases. It provides medicines for the treatment of cancer, other auto-immune diseases, central nervous system disorders, ophthalmological disorders, infectious diseases, and respiratory diseases. The company also offers in vitro diagnostics, tissue-based cancer diagnostics, and diabetes management solutions. Roche conducts research to identify novel methods to prevent, diagnose, and treat diseases. The company offers its products and services to hospitals, commercial laboratories, healthcare professionals, researchers, and pharmacists. Together with its subsidiaries and partners, the company has operations in various countries. Roche is headquartered in Basel, Switzerland.

The company reported revenues of (Swiss Francs) CHF62,801 million for the fiscal year ended December 2021 (FY2021), an increase of 7.7% over FY2020. In FY2021, the company’s operating margin was 28.9%, compared to an operating margin of 31.8% in FY2020. In FY2021, the company recorded a net margin of 22.2%, compared to a net margin of 24.5% in FY2020.

Quick View – Trastuzumab

Report Segments
  • Innovator (NME)
Drug Name
  • Trastuzumab
Administration Pathway
  • Intravenous
  • Subcutaneous
Therapeutic Areas
  • Oncology
Key Companies
Highest Development Stage
  • Marketed

GlobalData, the leading provider of industry intelligence, provided the underlying data, research, and analysis used to produce this article.

To create this model, GlobalData takes into account factors including patent law, known and projected regulatory approval processes, cash flows, potential applicable patients, drug margins, company expenses, and pricing estimates. Combining these data points with GlobalData’s world class analysis creates high value models that companies can use to help in evaluation processes for each drug or company.

The rNPV method integrates the probability of a drug reaching a clinical stage into the cash flow at that time, which provides a more accurate rNPV, as it considers the probability that the drug never makes it through the clinical pathway to commercialization. GlobalData’s rNPV model uses proprietary likelihood of approval (LoA)and phase transition success rate(PTSR) data for the indication in the highest development stage, which can be found on GlobalData’s Pharmaceutical Intelligence Center.