Samsung Bioepis (South Korea) has gotten an approval recommendation from the EMA for one of its 13 in-development biosimilars: Flixabi, a biosimilar of Janssen’s blockbuster Remicade for Inflammatory diseases.
It started developing a biosimilar pipeline back in 2012, for which the company is solely responsible of R&D, clinical trials and manufacture. The parent company Biogen, as well as MSD (Merck&Co), will take care of the commercialization for the ‘first wave‘ of Bioepis’ biosimilars.
One of these is Flixabi (SB2), which has now been recommended for approval by the EMA. The marketing authorization is now in the hands of the European Commission (EC).