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THE PHARMA REVIEW (JANUARY - FEBRUARY 2018)

Challenges To Generic Drug Development

Sridevi Krishnan

Introduction: The Hatch-Waxman Act of 1984 ushered in an era witnessing the balancing of interests of innovators and generics in the pharmaceutical space. From the point of view of the generics, it was the dawn of generic development in the US, made possible even during the life of innovatorís patent with certain restrictions in favour of the innovator. The current write-up reviews the challenges faced by a generic company during the generic drug development and deems the future of the pharmaceutical space to be in the development of complex generics such as biosimilars. 

 

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