'Ontruzant' (ingredient name: trastuzumab, project name: SB3), an anti-cancer drug developed by Samsung Bioepis, received the European Commission (EC)’s marketing authorization for the first time as a biosimilar referencing Herceptin.
On November 20, Samsung Bioepis announced the European Commission (EC)’s marketing authorization of Ontruzant, an anti-cancer biosimilar.
Ontruzant is a biosimilar referencing Herceptin (trastuzumab) of multinational pharmaceutical company Roche based in Switzerland, for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. Herceptin is the world's eighth best-selling biosimilar. The drug posted about 7.8 trillion won in sales last year.
The approval came in only two months since Ontruzant received an affirmative opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) in September.
Samsung Bioepis expects that this authorization will empower Ontruzant to secure an advantageous position in the market by becoming the first Herceptin biosimilar in Europe by beating competitors that applied for authorization during similar periods.
Currently, in Europe, Celltrion applied for permission to sell a Herceptin biosimilar in October of last year and Amgen and Allergan in March of this year. Now they are waiting for results.
This approval means that Samsung Bioepis received marketing approval of an anti-cancer drug for the first time apart from autoimmune disorder drugs. Ontruzant is the fourth biosimilar developed by Samsung Bioepis that received EC marketing authorization.
In addition, this authorization made Samsung Bioepis the company with the largest number of biosimilars referencing the top ten drugs in global sales.