Can you discuss each phase -- manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation -- in the approach to regulatory approval of biosimilars?

Can you discuss each phase -- manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation -- in the approach to regulatory approval of biosimilars?

Can you discuss the clinical and pharmacologic implications of each phase — manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation — in the stepwise approach to regulatory approval of biosimilar therapies, with a focus on infliximab and its biosimilar, as INFLIXIMAB-DYYB (INFLECTRA®), which is now available for RA and related disease states?


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