Celltrion files Remsima in the United States:
Celltrion announced that the company, on August 8, 2014, completed the filing procedure to obtain US FDA approval for its infliximab biosimilar. This marks the first 351(k) biosimilar mAb application to be filed in the U.S.A. and the second application for a biosimilar to be filed through the US BPCIA.
Filed under: ANTIBODIES, Biosimilar drugs, Monoclonal antibody Tagged: biosimilars, celltrion, files, infliximab, Monoclonal Antibodies, Remsima, united states
