Posted by Michael Wonder on 20 Jul 2019
EU starts evaluating Samsung Bioepis’ sales application for Avastin biosimilar
19 July 2019 - Samsung Bioepis said that the EMA has started evaluating its application to market SB8, an Avastin biosimilar product.
The company submitted a marketing authorisation 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 anti-cancer, 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.
