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Biosimilar Interchangeable Exclusivity Guidance Still Planned Despite Memo Release, US FDA Says

 
• By Derrick Gingery

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.

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Many concepts in the memo could be reflected in upcoming guidance on biosimilar first interchangeable exclusivity. • Source: Shutterstock

More guidance on biosimilar first interchangeable exclusivity is coming that could compliment or expand on information in a memo that included the US Food and Drug Administration’s interpretation of several critical legal questions in the area.

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