Mass spectrometry (MS) is one of the key analytical techniques to detect and to identify
primary sequence differences, to assess similarity and to evaluate batch variability of …

1.1. Biosimilar proteins and glycoproteins in Europe: definitions and status The clinical and
commercial success of biologic-derived drugs is transforming the pharmaceutical industry. In …

• Extensive biosimilar/reference mAb comparison is required in biosimilar development.• In
EU and USA, biosimilar/reference mAb primary amino-acid sequences must be the same.• …