2017 Clinical Trial Strategies & Trends in Biosimilar Drug Development: A higher proportion of bioisimilar development projects is targeted towards regulated markets

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Dublin, Jan. 12, 2018 (GLOBE NEWSWIRE) -- The report has been added to 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.

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Related Topics: Drug Discovery, Clinical Trials, Biosimilars and Biosuperiors

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Globe Newswire: 10:06 GMT Friday 12th January 2018

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