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

Name: Can you discuss each phase -- manufacturing, efficacy and safety testing, PK/PD evaluation, clinical outcomes evaluation -- in the approach to regulatory approval of biosimilars?
Uploaded: 2018-06-06T00:00:00+00:00
Description: 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?

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Created by

Presenter

Jonathan Kay, MD

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

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