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Biosimilars: FDA, EMA Developing Common Data Package Guidance

 
• By Derrick Gingery

Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.

FDA and its European colleagues appear closer to creating guidance outlining how sponsors could use reference products licensed outside their respective regions as the basis for a biosimilar application, although it is unclear when such a document could be released.

FDA does not have anything that appears directly related to the subject on its list of guidance documents expected in...

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