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

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 cannot make an application approval effective, as well as remove...