Monoclonal antibodies (mAbs) are becoming one of the important classes of biomolecules for the treatment of various cancers. Biosimilar mAbs, which are the replica of the licensed innovator product in the market are also gaining lots of attention. According to the FDA definition1 , “Biosimilars are a type of biological product that are licensed (approved) by FDA because they are highly similar to an already FDA-approved biological product, known as the biological reference product (reference product), and have been shown to have no clinically meaningful differences from the reference product.” The development of these biosimilars is expanding due to the patent expiry of innovator drugs. Many biopharmaceutical companies are involved in the manufacturing of these biosimilars, more so in developing countries. LC/MS characterization is a powerful and essential tool to show comparability between innovators and biosimilars.
Publication number: 5991-6522EN
Publication Date: January 1, 2016