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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While many interpretations of the law protecting the first interchangeable biosimilar approved for a reference product are included in a recently released FDA memo, the agency says it has a limited scope.
Stakeholders may be irked that the agency chose to release a memo on its interpretation of the first interchangeable exclusivity law before issuing formal guidance.
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