Biosimilar infliximab regulatory update

FDA accepted for review a BLA from Samsung Bioepis Co. Ltd. for SB2, a biosimilar of Remicade infliximab, to treat rheumatoid arthritis (RA), Crohn’s disease (CD), ulcerative colitis (UC), ankylosing spondylitis, psoriatic arthritis and psoriasis. The company declined to disclose the PDUFA date. The BLA is the first submitted in the U.S. by Samsung Bioepis, a JV between Samsung BioLogics and Biogen. Samsung Biologics is a JV between Samsung Group and Quintiles Transnational Corp. (NYSE:Q, Research Triangle Park, N.C.). ...