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.

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.
Country | Marketing time | Indication |
U.S. | 1998 | Breast cancer, gastric cancer |
Canada | 1999 | Breast cancer |
Switzerland | 1999 | Breast cancer, gastric cancer |
EU | 2000 | Breast cancer, gastric cancer |
Japan | 2001 | <...
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