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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.

Key Takeaways

  • The FDA still plans to publish guidance on biosimilar first interchangeable exclusivity, where many of the interpretations in the memo could be repeated.

The memo describing the FDA’s first interchangeable exclusivity decision for Boehringer Ingelheim GmbH’s Cyltezo, an interchangeable biosimilar of...

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