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Could US FDA User Fee Bill Include The Long-Sought 505(b)(2) Pathway For Biosimilars?

 
• By Derrick Gingery

Former FDA official says the pathway is needed to avoid wasted sponsor time and effort.

Road construction
Congress could consider creating a 505(b)(2)-like pathway for biosimilars in upcoming FDA-focused legislation. • Source: Alamy

A 505(b)(2)-like pathway for biosimilars could make the agenda for the upcoming US Food and Drug administration bills, given its potential to streamline approval of some products and encourage innovation.

The generics pathway allows the applicant to rely on some data that the others developed to gain approval

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More from Biosimilars & Generics

US FDA Shows Support For Generic Drug User Fee Goals Amid Cutbacks

 
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