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FDA updates purple book for biologicals and biosimilars

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FDA updates purple book for biologicals and biosimilars

On 21 February 2017, the US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) announced the availability of an updated version of the ‘Purple Book’.

The Purple Book is a set of lists of licensed biological products and biosimilars that are meant to be the biological equivalent of the ‘Orange Book’, which lists pharmaceuticals and their generic equivalents.

FDA published the first-ever edition of the Purple Book in September 2014 [1]. The book lists biological products, including any biosimilar and interchangeable biological products licensed by FDA. It includes the date of licensure of the reference product, whether a product is biosimilar or interchangeable and reference product exclusivity expiry dates.

Fuente: GaBi Online



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