Is CREATES Act Equipped To Handle Biosimilar Complaints?
Executive Summary
Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
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Senate’s US FDA User Fee Bill Answers Biosimilar Interchangeable Exclusivity Questions
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Shared First Interchangeable Biosimilar Exclusivity May Be Allowed Under US FDA User Fee Bill
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