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How "similar" are biosimilars to the originator product? What confidence intervals are acceptable and what level of analytical rigor and drift are acceptable?

How “similar” are biosimilars to the originator product? What confidence intervals are acceptable and what level of analytical rigor and drift are acceptable? What parameters must be synchronized between the originator and biosimilar to meet regulatory approval.


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