“…Other articles focus on characterizing the relationship between product quality characteristics (e.g., structural and functional characterization) and clinical performance to further streamline clinical development 7–9 . Global alignment of regulatory expectations for biosimilar approval makes biosimilar development more efficient and attractive to sponsors, and we are happy to see articles in this issue from regions around the world; in addition to the United States, this includes articles with viewpoints from Canada, 10 Europe, 7 India, 11 and Japan 12 . Finally, other articles focus on the importance of educating clinicians and patients about biosimilars and assessing the cost to patients.…”