Since the efficacy of biosimilars is typically studied for a single indication, why are approvals of such biosimilars as INFLIXIMAB-DYYB extended to other diseases in which the biosimilar was not tested directly against the reference

Name: Since the efficacy of biosimilars is typically studied for a single indication, why are approvals of such biosimilars as INFLIXIMAB-DYYB extended to other diseases in which the biosimilar was not tested directly against the reference
Uploaded: 2018-06-06T00:00:00+00:00
Description: Since the clinical efficacy of biosimilars is typically studied for a single indication, why then are approvals of such biosimilars as INFLIXIMAB-DYYB, for example, extended to other disease states in which the biosimilar was not tested directly against the reference product? Can you discuss the concept of “extrapolation of indications” as it relates to biosimilars?

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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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