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

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
Pink Sheet Podcast

Learn what's happening at the US FDA. On the go.

Derrick Gingery and the team bring you a weekly "Drug Fix".

More from Biosimilars

More from Biosimilars & Generics