Biosimilars: Postmarketing Data Alone Not Enough For Interchangeability

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data needs, but not as basis for securing an interchangeability designation absent a clinical, multi-switching study, draft guidance states.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to supplement clinical switching study data for certain types of products, the US FDA said in its long-awaited draft guidance on interchangeability.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)...

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