Generic Industry Wants US FDA To Consider Allowing Foreign Reference Products For ANDAs

 
• By Derrick Gingery

If agency adopts policy, it might obviate the need for the CREATES Act. Biosimilars already enjoy a degree flexibility of on the source of reference material that generic sponsors want extended to the less complicated small molecule drugs.

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Allowing bridging of US and foreign reference standards could lower generic drug development costs, the industry argues. • Source: Shutterstock

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