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Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions

 
• By Derrick Gingery

The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.

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The Senate bill would address some biosimilar questions, but others still linger • Source: Shutterstock

Biosimilar sponsors would gain a tentative approval pathway and shared exclusivity for interchangeable products in the Senate version of the US Food and Drug Administration user fee reauthorization bill, answers to long-pondered questions about the products’ regulation.

The bill, released on 17 May, would rewrite a section of the biosimilar law to state that the FDA...

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