Samsung Bioepis submits MAA for Remicade biosimilar

Samsung Bioepis Co. Ltd., a JV between Samsung Group (Seoul, South Korea) and Biogen Idec Inc. (NASDAQ:BIIB), submitted an MAA to EMA for SB2, a biosimilar of autoimmune drug Remicade infliximab from Merck & Co. Inc. (NYSE:MRK) and Johnson & Johnson (NYSE:JNJ).

The submission is based on results from head-to-head studies against Remicade including preclinical work, Phase I trials and a Phase III study in patients with moderate to severe rheumatoid arthritis (RA). ...