Celltrion files for Approval of Remicade Biosimilar in US

Celltrion, a Korean biotech, filed with the FDA for approval of Remsima®, a biosimilar to Janssen’s Remicade, which is indicated for autoimmune diseases. Remsima is the first monoclonal antibody to seek approval in the US under the 351(k) rules for biosimilars. In 2009, Celltrion and Hospira agreed to become co-exclusive distributors of Remsima as part of a package of eight biosimilars (now expanded to eleven) under development at Celltrion. More details.... Stock Symbols: (KOSDAQ: 068270) (NYSE: HSP) Share this with colleagues: // //