Samsung Bioepis said that the European Medicines Agency (EMA) has started evaluating its application to market SB8, an Avastin biosimilar product.
|Samsung Bioepis headquarters in Songdo, Incheon.|
The company submitted a marketing authorization application to the EMA in June. With the start of the screening process, Samsung Bioepis has become the first Korean firm to kick off its marketing approval process for the anticancer, antibody biosimilar in the global market.
SB8 is the second oncology biosimilar developed by Samsung Bioepis and will mark the fifth biosimilar product that the company plans to launch in the global market. The company currently sells Benepali, Flixabi, Imraldi, and Ontruzant in the EU. The company also plans to present global phase 3 trial results for SB8 at the European Society for Medical Oncology in September.
Avastin, developed by Roche, treats metastatic colorectal cancer, non-small cell lung cancer, and metastatic breast cancer. The drug recorded a global sale of 8.2 trillion won ($6.9 billion) last year.