[Structural characterization and analysis of Omalizumab and its biosimilar CMAB007 by LC-MS].

We compared the similarity of Omalizumab (Xolair; a humanized anti-immunoglobulin E monoclonal antibody) and it's biosimilar CMAB007. An in depth characterization of a candidate biosimilar was carried out using a systematic approach, the approach provides a set of routine tools that combine accurate intact mass measurement, peptide mapping, and released glycan profiling. CMAB007 and Omalizumab had the same primary structure and exhibited almost the same content of C-terminal lysine variants. The types of detected free oligosaccharides were very similar, such as sialylation, fucosylation and high mannose types. CMAB007 could be considered as a highly similar molecular to Omalizumab and expected to be the first humanized anti-immunoglobulin E monoclonal antibody drug in China.