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Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity

 
• By Derrick Gingery

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.

Railway tracks with switches and interchanges at a main line in Germany with geometrical structures black and white
First interchangeable exclusivity guidance is one of several the FDA is writing in the interchangeability area • Source: Shutterstock

US Food and Drug Administration officials are moving to set biosimilar interchangeability exclusivity policy as some products seeking the designation may be approaching the approval stage.

The first interchangeable biosimilar approved is entitled to one year of exclusivity per the Biologics Price Competition and Innovation Act (BPCIA). Eva Temkin, acting associate director for policy in the...

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