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Interchangeable Biosimilars: FDA Clarifies US Reference Not Mandatory For Studies

Executive Summary

Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.

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Biosimilar Interchangeability Switching Studies May Use Foreign Comparators, US FDA Says

But scientific bridging required for non-US reference products might be more extensive than in other contexts, agency cautions; easing of the US comparator-only recommendation is one of several changes from the 2017 draft guidance that could make pursuing an interchangeability designation easier.

Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’?

US FDA and PhRMA may be headed for showdown over use of foreign reference product bridging studies; PhRMA says that relying on sponsor’s non-public information to waive bridging studies  would violate firm’s commercial confidential information, while FDA Commissioner Gottlieb sees ‘public health prerogative’ in considering whether data-sharing agreements with foreign regulators could help eliminate need for unnecessary studies.

Biosimilar Bridging Study Waivers: Public Health Prerogative Or Trade Secret ‘Taking’?

US FDA and PhRMA may be headed for showdown over use of foreign reference product bridging studies; PhRMA says that relying on sponsor’s non-public information to waive bridging studies  would violate firm’s commercial confidential information, while FDA Commissioner Gottlieb sees ‘public health prerogative’ in considering whether data-sharing agreements with foreign regulators could help eliminate need for unnecessary studies.

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