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# Concerns Over FDA Biosimilar Labeling Draft Guide
- URL: https://www.fdaweb.com/concerns-over-fda-biosimilar-labeling-draft-guide/
- Published: 2023-11-21T12:00:00.000Z
- Updated: 2026-09-14T14:16:46.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5155839

Pharmaceutical Research and Manufacturers of America (PhRMA) says it is concerned by an FDA proposal to eliminate the parallel interchangeability statement and footnote currently in the labeling of some biosimilar products listed as interchangeable. The proposal is part of an agency draft guidance on labeling for biosimilar and interchangeable biosimilar products.

The PhRMA [comment letter](https://www.regulations.gov/comment/FDA-2016-D-0643-0088?ref=fdaweb.com) recommends that the interchangeability statement be retained and refined as described in its letter. The association also says it is concerned that the agency apparently began implementing the draft guidance before the comment period closed, “which undermines the public comment process and conflicts with statutory and regulatory provisions on guidance documents.”

The Biosimilar Council [says](https://www.regulations.gov/comment/FDA-2016-D-0643-0087?ref=fdaweb.com) it applauds FDA’s work to clarify that, as a scientific matter, there is no difference between biosimilars and interchangeable biological products, with the draft guidance seen as another step forward.

The council recommends that the final labeling guidance provide additional background on the updated thinking and changed perspective of FDA from 7/2018 to 9/2023\. It makes additional general recommendations and also includes specific recommended changes.

The Biotechnology Innovation Organization [submits](https://www.regulations.gov/comment/FDA-2016-D-0643-0086?ref=fdaweb.com) specific comments on the interchangeability statement on product labeling, the biosimilar statement on product labeling, and the naming convention. It also submits line-by-line recommended edits.

The U.S. Pharmacopeia (USP) [says](https://www.regulations.gov/comment/FDA-2016-D-0643-0082?ref=fdaweb.com) it remains “highly supportive of FDA’s efforts to create efficient and predictable pathways for biologic drug development under the Biologics Price Competition and Innovation Act, as well as efforts to promote a competitive marketplace for biosimilar alternatives….” The letter says USP expert volunteers believe that FDA’s proposal to provide information on biosimilarity within the biosimilarity statement and to omit information regarding the interchangeability standard from a labeling statement “does not pose a concern from a therapeutic perspective, nor does it impact pharmacy-level substitution of interchangeable biosimilar products, as in practice, relevant, core product information is sourced from information specific to the biosimilar or interchangeable biosimilar product.”