Receptor-binding hydrogen–deuterium exchange mass spectrometry as an additional measurement of biosimilarity

Purpose Biosimilars can effectively reduce the cost of healthcare by providing a new source of competition for original drugs. A cornerstone of biosimilar development is assembling a comprehensive package of analytical data that demonstrates physicochemical biosimilarity to justify a shorter regimen of clinical trials. The purpose of the present work was to present part of a biosimilarity data package comparing Pfenex pegfilgrastim to its reference, Amgen’s Neulasta™ and to highlight a deuterium exchange experiment that can be used as part of the analytical tool box to demonstrate biosimilarity.