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Press Release

World Clinical Trial Strategies in Biosimilar Drug Development Report 2017 - Research and Markets

Research and Markets
Posted on: 09 Nov 17

The "Clinical Trial Strategies in Biosimilar Drug Development" report has been added to Research and Markets' offering.

As the patent cliff for many blockbuster biologic therapies is approaching, clinical development programs for biosimilar options to those therapies are emerging at a rapid pace. Among the key areas of development is biologics in the autoimmune/inflammation, oncology, and endocrinology/nephrology space. Sponsors of biosimilar projects are carefully designing their trials, assessing the most suitable target populations, and geography.

The concept of interchangeability in the US, where a reference product and a biosimilar are considered freely interchangeable, is not seen in Europe or other developed regions. By gaining an interchangeability status, a biosimilar may greatly enhance its uptake, however the FDA requires that the applicant should strictly adhere to the recently issued Guidelines on Interchangeability.

The guideline asks sponsors to conduct a tailored clinical investigation containing multiple elements of switching between the brand and biosimilar as a proof that switching is a safe practice. This report outlines the approaches to switching that various sponsors have adopted prior to the availability of the FDA guidance, and after its publication.

Key Topics Covered:

1 Executive Summary

2 Overview Of Clinical Trial Strategies

3 Global Trends In Biosimilar Clinical Trials

4 Autoimmune/Inflammation Biosimilar Trial Trends

5 Oncology Biosimilar Trial Trends

6 Endocrinology/Nephrology Biosimilar Trial Trends

7 Biosimilar Trial Trends In Other Therapeutic Areas

8 Phase III Switching Study Designs And Biosimilar Interchangeability

9 Appendix

For more information about this report visit

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Business Wire

Last updated on: 09/11/2017

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