FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

  • By: Staff Editor
  • Date: January 18, 2017
  • Source:
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FDA Releases Long Awaited Biosimilar Interchangeability Draft Guidance

The US FDA has finally issued its much awaited draft regulation on biological product interchangeability. The regulatory guidance has been expected since 2010, when Patient Protection and Affordable Care Act was signed into law, that amended the Public Health Service Act to create an abbreviated license pathway for biological products that are proved to be biosimilar or interchangeable with an FDA-licensed biological product.

This guidance offers a summary of vital scientific and technical aspects in representing interchangeability with a reference product, including the following:

  • Data required to support a demonstration of interchangeability,
  • Concerns for the design and investigation of a switching study or studies to support a demonstration of interchangeability,
  • Suggestions regarding the use of a U.S. licensed reference product in a switching study or studies,
  • Considerations for developing presentations, container closure systems, and delivery device constituent parts for planned interchangeable products.

Background: Biosimilar and Interchangeability

A biosimilar is a biological product that is very much similar to an FDA approved biological product, known as a reference product, and has no clinically significant difference in terms of safety and effectiveness from the reference product.

An interchangeable biological product is biosimilar to an FDA recognized reference product and meets additional standards for interchangeability.

Since 2015, the US FDA has approved only four biosimilar products under section 351(k) of the Public Health Service Act.

Comment Period

FDA is currently accepting comments on this guidance document. Comments submitted by March 19, 2017 will be considered in the development of the final version of this guidance.

Related Training:

FDA's Rules for the Development and Approval of Biosimilars

Biosimilars Analytical Characterization and Comparability Studies

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