During the production of a biosimilar, there are certain points that need to be addressed to ensure its safety and efficacy. In this video, Richard Markus, MD, PhD, of Amgen, Los Angeles, CA, discusses the three most important factors to consider, explaining their importance and how the study design used by Amgen addresses these points. This interview was recorded at the 2017 European Society for Medical Oncology (ESMO) conference held in Madrid, Spain.