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Interchangeability Of Biological Drug Products-FDA Draft Guidance.

Laszlo Endrenyi^1,2, Richard Markus³

¹University of Toronto, Toronto, ON, Canada.

Journal of Biopharmaceutical Statistics

|April 27, 2019

Summary

The Biological Price Competition and Innovation Act guides biosimilar development. This summary reviews FDA draft guidance on demonstrating biosimilar interchangeability and discusses current issues.

Keywords:

Interchangeability alternation biosimilars substitution switching

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Area of Science:

Biopharmaceutical regulation
Drug development and approval

Background:

The Biological Price Competition and Innovation Act (BPCI Act) of 2009 created the US pathway for biosimilar and interchangeable biosimilar approvals.
The Food and Drug Administration (FDA) has released multiple guidances to implement the BPCI Act for biosimilar development and assessment.

Purpose of the Study:

To summarize the FDA's draft guidance on scientific considerations for demonstrating interchangeability.
To briefly discuss current issues related to biosimilar interchangeability.

Main Methods:

Review of the FDA's draft guidance on interchangeability of biological products.
Analysis of scientific considerations for demonstrating interchangeability with a reference product.

Main Results:

The draft guidance outlines key scientific factors for assessing interchangeability.
Several ongoing issues and considerations regarding biosimilar interchangeability were identified.

Conclusions:

The FDA's draft guidance provides a framework for evaluating biosimilar interchangeability.
Further discussion and clarification on specific issues are needed to advance biosimilar adoption.