Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity
First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity
The first biosimilar with interchangeability status compared to its reference will be entitled to one year of exclusivity, a largely overlooked advantage in the early days of the US biosimilar market.
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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.
The bill would allow for tentative interchangeable approvals, as well as shared first interchangeable exclusivity for multiple first filers.
Legislation in development also could create an option for tentative approval of interchangeable biosimilars.