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

 
• By Sue Sutter

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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Who will control the board – public health or proprietary information arguments?

The US FDA and the innovator biopharmaceutical industry may be headed for a showdown over the use of foreign reference biologics in biosimilar development programs, pitting what the agency views as a public health issue against industry’s protection of its trade secrets.

The agency is considering whether bridging studies are necessary to establish that US-licensed and foreign-licensed reference biologics are the same...

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