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Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill

 
• By Derrick Gingery

Legislation in development also could create an option for tentative approval of interchangeable biosimilars.

shared biosimilar exclusivity
Sponsors may be confused by the statutory language governing first interchangeable exclusivity and whether multiple first filers could share it. • Source: Nielsen Hobbs; the Pink Sheet | Shutterstock image

Interchangeable biosimilar sponsors may gain the ability to share the associated exclusivity, similar to what often occurs among small-molecule generics.

A bill in development would ensure all sponsors who are the “first filers” for interchangeable status can receive the one...

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FDA employees are concerned that while the budget authority total proposed for fiscal year 2026 meets the user fee appropriations' triggers, the FDA could have trouble meeting allocation triggers without cuts to non-review work.

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• By Urtė Fultinavičiūtė

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