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Bydureon Approval Provides Lesson In Clinical Data Requirements For Biosimilars

 
• By Sue Sutter

Changes in the manufacturing site and production scale for exenatide extended-release complicated FDA’s review of Bydureon, Amylin’s follow-on agent to Byetta, and late-rising questions about the drug’s QT effects made FDA revisit its earlier conclusion that the investigational and commercial formulations were comparable. The agency’s decision to require additional clinical data in a second “complete response” letter suggests biosimilar sponsors will face a similarly high clinical hurdle.

The circumstances surrounding the review and delayed approval of Amylin Pharmaceuticals Inc.’s Bydureon highlight the manufacturing challenges that lie ahead for companies moving into the biosimilar space.

Use of an exenatide extended-release (LAR) formulation in the Bydureon clinical development program that differed from the proposed commercial formulation...

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• By Bridget Silverman

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