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Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability

 
• By Sue Sutter

US FDA sees role for postmarketing data to help address residual uncertainties and determine additional data needs, but not as basis for securing an interchangeability designation absent a clinical, multi-switching study, draft guidance states.

Biosimilar postmarketing data alone would be insufficient to support a demonstration of interchangeability but may be helpful, or even required, to supplement clinical switching study data for certain types of products, the US FDA said in its long-awaited draft guidance on interchangeability.

The guidance’s postmarketing data provisions leave the door open to the possibility that a company could submit an original 351(k) application that simultaneously seeks

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