Samsung Bioepis announced on December 20 that it filed a new drug application for its SB3 in the United States in October this year and the U.S. Food and Drug administration (FDA) recently initiated its procedure regarding the biosimilar for breast cancer treatment.
The SB3 is a biosimilar based on Roche’s Herceptin for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer. Last year, the Herceptin ranked eighth in terms of global biomedicine sales. The sales of the medicine amounted to 7.8 trillion won (US$7.0 billion) worldwide and 2.8 trillion won (US$2.5 billion) in the United States alone in 2016.
The SB3 has obtained permission by the name of Samfenet in South Korea and Ontruzant in Europe. The product name to be used in the United States has not been made public yet owing to the lack of permission.
Once the permission is granted, MSD, which is in partnership with Samsung Bioepis, will be in charge of the sale of the SB3 in the United States.