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Herceptin has been Excellent over the Two Decades

April 10, 2019 By Miling
Tag: Roche , Herceptin , HER2

The subcutaneous injection: Herceptin Hylecta of the star drug Herceptin under Roche has recently been approved by FDA for: a. HER2-positive early breast cancer in combination with chemotherapy; b. HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. This approval will strengthen the anti-cancer effects of Herceptin, and means another advancement of Herceptin. Since first approved in 1998, Herceptin has been very excellent over the two decades, continued to “seize territory”, and received wide recognition, with sales on the rise! Next, let’s see the glorious development road of the drug.

Herceptin has been Excellent over the Two Decades

I. About Herceptin: Born for excellence

Herceptin (generic name: trastuzumab) is a targeted drug acting on HER2 target, which is currently used as a single agent for treatment of metastatic breast cancer in patients who have received one or more chemotherapy regimens and in combination with paclitaxel to treat metastatic breast cancer in patients who have never received chemotherapy; furthermore, it can also be used in combination with capecitabine or 5-fluorouracil, for the treatment of patients with HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma, who have not received prior treatment for metastatic disease. First approved for marketing in the U.S. in 1998, the drug’s sales have continued to rise owing to the excellent therapeutic effects, and exceeded USD 6 billion in 2016.

It is natural that such an excellent drug is eyed covetously by many generic drug enterprises which have began to register for marketing their Herceptin generic drugs (biosimilars) since the original drug patent of Herceptin expired in 2016. For example, the FDA has approved many Herceptin biosimilars such as the trastuzumab of Samsung Bioepis; and there have been many Chinses pharmaceutical enterprises participating in Herceptin imitation, wherein, 3SBio’s Herceptin biosimilar has been applied for marketing in Sep. 2018.

In the same time, Roche is laying out further R&D of Herceptin, to cope with expiration of original drug patent. Herceptin Hylecta has been launched under such background, which is constituted by the intravenous injection monoclonal antibody: trastuzumab and recombinant human hyaluronidase: PH20 and administered through subcutaneous delivery. Herceptin Hylecta is a ready-to-use preparation that can be administered in 2 to 5 minutes, compared to 30 to 90 minutes for intravenous Herceptin. This advantage will bring guarantee for Roche to maintain its market share.

II. Approval process of Herceptin in the world: “capture territory in an invincible manner”

Herceptin was first marketed in the U.S. in 1998. The following table shows the marketing time of the drug in countries and regions of the world.


Marketing time




Breast cancer, gastric cancer



Breast cancer



Breast cancer, gastric cancer



Breast cancer, gastric cancer



Breast cancer, gastric cancer



Breast cancer

Table I Marketing Time of Herceptin in Countries and Regions in the World

We can see from the above table that Herceptin has been approved for marketing in the major drug markets in the world, and was marketed in China early in 2002. And its indications have increased from the original breast cancer, to gastric cancer in many countries and regions such as the U.S. and EU. Next, I’d like to sort out the approval of its gastric cancer indication which is relatively not familiar to us. The indication of trastuzumab in combination with chemotherapy for HER2-positive metastatic gastric cancer was applied for in Switzerland in 2009; this indication was approved in EU and U.S. thereafter in 2010, and in Japan in 2011.

And with this approval of the subcutaneous injection: Herceptin Hylecta, Herceptin can be said to have “captured territory in an invincible manner”, and benefited innumerable patients.

III. About HER2 target: the start target leading to a myriad of star drugs

HER2 is a star therapeutic target people have heard about it. In terms of breast cancer patients, HER2-positive patients account for 25-30% thereof, therefore, HER2 targeted drugs is of great significance to the treatment of the disease.

Drug name

Developed by




Prostatic cancer, and non-small cell lung cancer, etc.



Prostatic cancer, etc.



Non-small cell lung cancer, etc.


Boehringer Ingelheim

Non-small cell lung cancer



Breast cancer



Non-small cell lung cancer


Jiangsu Hengrui

Non-small cell lung cancer, etc.

Table II Major HER2 Targeted Drugs Marketed

Table II lists some of the major HER2 targeted drugs marketed. Besides biological targeted drugs such as Herceptin and pertuzumab, there are also many small molecule HER2 targeted drugs such as lapatinib, afatinib, neratinib, and dacomitinib, which play an important role in their corresponding disease areas. We can also see from the above table that this hot target has attracted attention of global pharmaceutical giants like Roche, Pfizer, and Novartis. It can be called a star target that has led to a myriad of star drugs and made many successful pharmaceutical giants.

IV. Conclusion

Herceptin is of much significance to the medical world, and has brought benefits to innumerable cancer patients. According to research, currently, there are 2,563 clinical studies, over 6,600 literature reports, and 238 patents on Herceptin in the world. Guaranteed by so many data and tested by over 2 decades of application, the efficacy of Herceptin is beyond all doubt. A movie Living proof was even made for the drug in the U.S. To sum up, Herceptin has been excellent over the two decades.




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