Agency outlines flexible, case-by-case approach to demonstrating interchangeability to reference products; emphasizes role of “switching studies” -

On January 18, 2017, the US Food and Drug Administration (FDA or Agency) issued its highly anticipated draft guidance on demonstrating interchangeability under the Biologics Price Competition and Innovation Act (BPCIA). The draft guidance, titled Considerations in Demonstrating Interchangeability With a Reference Product, provides FDA’s thinking on the types of studies that biosimilar product sponsors should conduct and the data sponsors should provide to support a finding that a proposed biosimilar product is interchangeable with a reference biologic. The draft guidance marks an important milestone in FDA’s ongoing efforts to implement the BPCIA. While the draft guidance is focused on therapeutic protein products, the principles it articulates may apply to demonstrations of interchangeability more broadly.