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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Commissioner Scott Gottlieb says move could allow biosimilar sponsors to avoid anti-competitive efforts by brand sponsors in US.
Draft guidance strongly recommends against it, but US FDA's Leah Christl says agency is willing to talk about using foreign-licensed comparators.
Bridging studies conducted between local and foreign versions of the same reference product are redundant, costly and not scientifically necessary for biosimilar development, consultants Christopher Webster and Gillian Woollett write; authors suggest three criteria for global acceptance of a single comparator.