What is the important, clinical and regulatory distinction between bioequivalency and interchangeability as it relates to biosimilar drugs and their reference product?

What is the important, clinical and regulatory distinction between bioequivalency and interchangeability as it relates to biosimilar drugs and their reference product?

What is the important, clinical and regulatory distinction between bioequivalency and interchangeability as it relates to biosimilar drugs and their reference product? What is the current guidance on studies for validating interchangeability?


Created by

CMEducation Resources IQ&A Interactive Intelligence Zone

Presenter

Jonathan Kay, MD

Jonathan Kay, MD

Director of Clinical Research
Rheumatology Division
Professor of Medicine
University of Massachusetts Medical School
Worcester, MA