FDA BsUFA Goals Letter Outlines Plans for Guidance, Pushes Back Timeline on Interchangeability Guidance

Interchangeability  •  Regulatory Guidances  •  U.S. FDA News

FDA has published its performance goals and procedures (commonly referred to as FDA’s “goals letter” or “commitment letter”) for the Biosimilar Biological Product User Fee Act (“BsUFA”) reauthorization for fiscal years 2018 – 2022, ahead of its upcoming public meeting on October 20, 2016 to discuss FDA’s proposed recommendations for the BsUFA reauthorization.

Among other things, FDA’s goals letter indicates that draft FDA guidance on considerations for designating biosimilars as interchangeable to a reference product may not be available until as late as December 31, 2017, with issuance of revised or final guidance pushed back until as late as early 2020.

Although FDA has previously declared plans to issue draft guidance on interchangeability sometime in 2016, the recently published goals letter indicates that FDA is pushing back its timeline by at least a year.  In the letter, FDA states:

A. On or before December 31, 2017, FDA will publish draft guidance describing considerations for designating biosimilar biological products as interchangeable to a reference product. FDA will work toward the goal of publishing a revised draft or final guidance within 24 months after the close of the public comment period. 

In other words: draft guidance on interchangeability can be expected by the end of 2017.  After allowing time for public comments on the draft, FDA will then aim to publish either a revised draft of the guidance (subject to further public comments) or a final guidance within two years.

FDA’s letter also lays out goals for issuing other guidance, including draft guidance on “statistical considerations for the analysis of analytic similarity data intended to support a demonstration of ‘highly similar’ for biosimilar biological products,” “processes and further considerations related to post-approval manufacturing changes for biosimilar biological products,” and revised draft guidance or final guidance on the following published draft guidance documents:

1. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product (draft guidance published in May 2014)

2. Nonproprietary Naming of Biological Products (draft guidance published in August 2015)

3. Labeling for Biosimilar Biological Products (draft guidance published in March 2016)

Stay tuned to the Big Molecule Watch for further developments.

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