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Make The ‘Purple Book’ More Orange, US FDA Told At Biosimilars Hearing

 
• By Sue Sutter

Listing patent and exclusivity information for novel biologics, as is done in the ‘Orange Book’ for small molecules, would help inform biosimilar development, stakeholders say at hearing on facilitating biologic competition and innovation; AbbVie urges FDA to use the Purple Book to clarify the scope of interchangeability decisions.  

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Making the US FDA’s “Purple Book” listing of licensed biological products more like its small molecule predecessor, the “Orange Book,” could help promote biosimilar competition, better inform prescribing and dispensing, and boost market uptake, stakeholders told the US FDA at a Sept. 4 hearing.

Listing patent and exclusivity information – as is done in the Orange Book – as well as the date of first licensure for all biological products in the Purple Book would help sponsors in deciding whether to pursue a biosimilar development program

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