Video

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?

Published: June 6, 2018

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

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?

Overview

CLICK HERE FOR CME CREDIT

Created by

Presenter

Jonathan Kay, MD

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

Related Videos

How do biosimilars differ from biomimics?

Video

What are the current price differences between the originator product such as brand/originator versions for infliximab versus the biosimilar? Does it vary from country to country?

What are the current price differences between the originator product such as brand/originator versions for infliximab versus the biosimilar? Does it vary from country to country? From Europe to the U.S.?

Video

What have we learned about the equivalency and outcome-based efficacy of biosimilars within the context of a “single switch” between the originator and biosimilar, including the NOR- SWITCH study; and what are the implications for clinical practice?

Video

Can you discuss study design, rationale, results, and clinical implications of the most recent clinical evidence focused on the safety, immunogenicity, and efficacy of approved biosimilar therapies for RA?

Can you discuss and explain the study design, rationale, results, and clinical implications of the most recent clinical evidence—i.e. clinical trial—focused on the safety, immunogenicity, and efficacy of approved biosimilar therapies for ...

Video

What steps in the development of an anti-TNF biosimilar such as infliximab ensure the likelihood that the reference product and biosimilar produce similar clinical effects?

What are the analytical steps in the development process of an anti-TNF biosimilar such as infliximab that will ensure the likelihood that the reference product and biosimilar produce similar clinical effects in patients?

Video

Even though biopharmaceuticals and biosimilars are made in different manufacturing contexts, do we have data to confirm that such differences are clinically insignificant in the case of biosimilars for infliximab used in RA?

Even though biopharmaceuticals and biosimilars are made in different manufacturing contexts—as opposed to small compound generic drugs—do we have enough data to confirm that such differences are clinically insignificant in the case of, ...

Video

What are the implications of using anti-TNF biosimilars for clinical practice in RA? For cost savings? What have we learned about biosimilars for infliximab in the setting of RA?

What are the implications of using anti-TNF biosimilars for clinical practice in RA? For cost savings? What have we learned from the studies about biosimilars for infliximab in the setting of RA?

Video

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, ...

Video

What do the clinician and pharmacist need to know as it relates to what drug will actually be dispensed to the patient when a prescription is issued for the biosimilar or reference drug?

From a practical perspective, what do the clinician and pharmacist need to know as it relates to what drug will actually be dispensed to the patient when a prescription is issued for the biosimilar or reference drug?