FDA to review Samsung Bioepis' Remicade biosimilar

Samsung Bioepis Co. Ltd. said FDA accepted its BLA for SB2, a biosimilar of autoimmune drug Remicade infliximab from Johnson & Johnson (NYSE:JNJ).

The BLA is the first submitted in the U.S. by Samsung Bioepis, a JV between Samsung Group (Seoul, South Korea) and Biogen Inc. (NASDAQ:BIIB). Merck & Co. Inc. (NYSE:MRK) has U.S. commercialization rights to SB2. ...