Herceptin (Trastuzumab)


Herceptin is the brand name of Trastuzumab; this monoclonal antibody is used to treat certain types of breast cancer or stomach cancer. This medication interferes with the growth and spread of cancer cells in the body.


The drug was first discovered by scientists including Dr. Axel Ullrich and Dr. H. Michael Shepard and Dr. Dennis Slamon studied Herceptin and finally discovered this drug.

  • In 1992: Genentech developed Herceptin jointly with UCLAY they began the first clinical trial with 15 women in 1992.
  • By 1996: This drug tried on over 900 women.
  • In September 1998, FDA tracked this drug very fast and gained approval.
  • Finally, in September 1998, US Food and Drug Administration (FDA) approved Herceptin for treating metastatic HER 2 over-expressing breast cancer.
  • In 2006: Herceptin was approved for use in early stage of  breast cancer besides standard breast cancer chemotherapy.
  • In 2014: according to a reprt Herceptinin combination with chemotherapy increased the 10-year chance of survival among breast cancer patients from 75 percent to 84 percent.
  • In 2014: Biocon Ltd and its partner Mylan got approval to sell a biosimilar but Roche’s litigation ended in 2016; so Biocon and Mylan started to produce their own branded biosimilars from 2016.

Medical uses

There are a great number of unique proteins called human epidermal growth factor receptor 2 protein (HER2) on the surface of the cancer cells in breast and stomach cancers.

It was approved that Herceptin can be used for treating HER2-positive stomach cancer that has spread to other parts of the body (metastatic gastric cancer) and also  Breast cancer that has large amounts of HER2+  on its cells.

Here are different ways of using Herceptin:

  • As part of a treatment period known as “AC→TH” that includes the chemotherapy drugs doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel.
  • As part of a treatment period known as “TCH” that includes chemotherapy drugs docetaxel and carboplatin
  • As a single treatment following anthracycline (doxorubicin) based therapy (a type of chemotherapy)
  • Patients are selected for therapy based on an FDA-approved test for Herceptin


Roche/Genentech’s patents expired in 2014 in Europe and will be expired 2019 in the United States, so around 20 companies all around the world  are working on developing biosimilar versions of the drug ‘Herceptin’ :

  • In 2013: Roche/Genentech had some difficulty with IP environment in India so they relinquished their patent right for the drug in this country.
  • In January 2015: Ministry of Health of the Russian Federation approved the first Herceptin biosimilar announced by BIOCAD.
  • In January 2016: Iran announced its own approved version of Herceptin and also declared its readiness to export the drug to other countries in the Middle-East and Central Asia after lifting of trade sanctions .
  • In December 2017: US FDA approved Trastuzumab-dkst (Ogivri, Mylan GmbH); it is used to treat breast cancer or gastric or gastroesophageal junction adenocarcinoma with overexpress the HER-2 gene.
  • In November 2017: Ontruzant received regulatory approval in Europe by European Commission. It was announced by Samsung Bioepis Co., Ltd.

These are some of the Herceptin biosimilars that are approved or in development.

  1. Actavis (Allergan)/Amgen/Synthon, USA/The Netherlands – ABP 980
  2. Alteogen/Cristalia, South Korea/Brazil – Phase I
  3. Apotex (Apobiologix), Canada – In pipeline
  4. Biocad, Russia- HERtiCAD (BCD-022)
  5. Biocon/Mylan, India/USA- CanMab/ Hertraz & Hercules (MYL-1401O)
  6. BioXpress Therapeutics, Switzerland – In pipeline
  7. Celltrion /Teva Pharmaceuticals Industries, South Korea/ Israel – Herzuma (CT-P6)
  8. EirGenix, Taiwan – EG12014
  9. Hanwha Chemical, South Korea- HD201
  10. Oncobiologics/Viropro, USA- ONS-1050
  11. Pfizer/Hospira, USA- PF-05280014
  12. PlantForm, Canada – On clinical Trial Phase
  13. Prestige Biopharma – HD201
  14. Samsung Bioepis (Biogen/Samsung)/Merck, South Korea/USA – Ontruzant (SB3)
  15. Shanghai CP Guojian Pharmaceutical, China- Saiputing
  16. Shanghai Henlius Biotech – HLX02

Gloal Market

Global Data that is a famous leader in providing business information and analytics conducted research; results show that the market for HER2-positive breast cancer treatments could grow from $6.4 billion in 2015 to $9.89 billion in 2025 with a compound annual growth rate (CAGR) of 4.4%. during this study, the HER2-positive treatment market was examined in the United States, the United Kingdom, France, Germany, Italy, Spain, Japan, and China.

They reported that the adjuvant and neo-adjuvant settings of the market will reach $4.96 billion by 2025, so they will be the main drivers of sales. It is expected that the monoclonal antibody pertuzumab (Roche’s Perjeta) is used in first-line therapy for HER2-positive metastatic breast cancer in combination with trastuzumab (Herceptin) and docetaxel be the biggest sales driver.

It is believed that pertuzumab and Herceptin complementarily increase the death of cancer cells, so according to the researchers’ opinion increased use of pertuzumab could help protect sales of Herceptin in a landscape with growing numbers of biosimilar options. According to the last published report, the adjuvant and neoadjuvant settings remain the greatest contributors to sales while it is expected that the combined forecasts reach $4.96 billion in 2025 that representing 50% of the total HER2-positive market.

The anticipated launch of Perjeta in the adjuvant setting primarily will drive the size of the market which will increase treatment duration compared to the neoadjuvant setting and also protect Herceptin sales from biosimilar erosion in established markets.

Top 10 Best-Selling Drugs for 2018

EvaluatePharma, a market research firm in a prediction reported the top 10 best-selling drugs for 2018. According to this report, Humira is the top best-selling drug in 2018 with sales of more than double the number two drug, Revlimid. Avastin (bevacizumab), Herceptin (trastuzumab), and Rituxan (rituximab) are anti-cancer drugs that are expected to generate approximately 6.4 billion in sales by 2018.

AbbVieHumira (Adalimumab)21 billion
CelgeneRevlimid (Lenalidomide)9.2 billion
Amgen/PfizerEnbrel (Etanercept)7.3 billion
Regeneron/BayerEylea (Aflibercept)6.5 billion
RocheAvastin (Bevacizumab)6.4 billion
RocheHerceptin (Trastuzumab)6.4 billion
RocheRituxan (Rituximab)6.4 billion
Johnson & JohnsonRemicade (infliximab)6.3 billion
Johnson & Johnson/BayerXarelto (Rivaroxaban)6.1 billion
MerckKeytruda (Pembrolizumab)6.1 billion

Global Breast Cancer Therapeutic Market

A study conducted by World Cancer Research Fund International (WCRF) conducted a study. The Results showed that has the highest percentage of breast cancer survivors after diagnoses devoted to North America while the lowest percentage is for developing countries of Asia and Africa. However, breast cancer continues to be a serious health concern in South America, Africa, and Asia.


According to the report of WRCF North America has a high incidence of breast cancer, but because of supportive insurance schemes meted by the government in this region the breast cancer therapeutics market is.

It is expected that the overall North American breast cancer therapeutics market surge at 7.3% CAGR between 2015 and 2023 during the forecast period. The only two key factors hampering this regional market are the risks of post-treatment complications and relapse.

Pouria Akhzary

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