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.
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Draft legislative text would allow some biologics and biosimilars to rely on published literature or other information and avoid some clinical studies, but the wide FDA discretion also included could raise more questions.
Republicans share brand industry worry about disclosure of confidential commercial information, suggesting changes may be possible during the upcoming full committee bill mark-up.
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.