Where does the evidentiary grounding come from to achieve FDA approval for a biosimilar? How many clinical trials are required to support the analytics? What end points are evaluated?

Where does the evidentiary grounding come from to achieve FDA approval for a biosimilar? How many clinical trials are required to support the analytics? What end points are evaluated?

Where does the evidentiary grounding come from to achieve FDA approval for a biosimilar? How many clinical trials are required to support the analytics? What end points are evaluated? Molecularly speaking, how close is the end result likely to be between the original and biosimilar?


Created by

CMEducation Resources IQ&A Interactive Intelligence Zone

Presenter

Joseph Markenson, MD

Joseph Markenson, MD

Department of Rheumatology
Department of Medicine
Hospital for Special Surgery, New York, NY
Attending Physician, Hospital for Special Surgery
Professor of Clinical Medicine, Weill Cornell Medical College