Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity

20 Nov 2020

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

Biosimilars: US FDA Developing Guidance For First Interchangeable Exclusivity

First Interchangeable Biosimilar Approved Is Entitled To One Year Of Exclusivity

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