On September 18, 2023, the FDA issued a new draft guidance “Labeling for Biosimilar and Interchangeable Biosimilar Products,” updating the previous labeling guidance “Labeling for Biosimilar Products” from July 2018.  According to the FDA, the significant changes from the prior guidance are on the following topics:

  • Labeling for interchangeable biosimilar products;
  • Product identification when the reference product labeling describes a clinical study conducted with a non-U.S.-approved biological product;
  • Pediatric use statements; and
  • Incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling

The new draft guidance also addresses comments received from the draft guidance “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” from November 2020.  Particularly, in the most recent guidance, the FDA changed its recommendation of inclusion of an interchangeability statement in the labeling for interchangeable products rather than a biosimilarity statement.  It now recommends both biosimilars and interchangeables include a biosimilarity statement, regardless of whether the product is a biosimilar or interchangeable, because “a labeling statement noting that certain products within a 351(k) BLA have been approved as interchangeable, and explaining the interchangeability standard is not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products.”  The FDA states that “information about interchangeability is more appropriately located in the FDA’s Purple Book rather than labeling.”

The new recommended biosimilarity statement for both biosimilar and interchangeable prescribing information is:

“Biosimilar means that the biological product is approved based on data demonstrating that it is highly similar to an FDA-approved biological product, known as a reference product, and that there are no clinically meaningful differences between the biosimilar product and the reference product. Biosimilarity of [BIOSIMILAR OR INTERCHANGEABLE BIOSIMILAR PRODUCT’S PROPRIETARY NAME] has been demonstrated for the condition(s) of use (e.g., indication(s), dosing regimen(s)), strength(s), dosage form(s), and route(s) of administration described in its Full Prescribing Information.”

The FDA requests comments on this biosimilarity statement as well as “how useful such biosimilarity statements have been for healthcare practitioners and the public, whether such statements can be improved to provide more clarity on what biosimilarity means, and whether biosimilar and interchangeable biosimilar product labeling should include such a statement at all.”

Additional recommendations include guidance on incorporating immunogenicity data and pediatric use data in the label.

Comments on the draft guidance are open through November 17, 2023.

To date, the FDA has approved 42 biosimilars and four interchangeables.  For more information on these approvals and related patent disputes, visit BiologicsHQ.


The draft guidance can be found here.

The September 2023 update of “Biosimilarity and Interchangeability: Additional Draft Q&As on Biosimilar Development and the BPCI Act” can be found here.


The author wishes to thank April Breyer Menon for her contribution to this article.


    Information contained in the Venable BiologicsHQ database relates to FDA-approved drug products listed in the CDER Purple Book or on the FDA website ( Information relating to FDA licensed products, FDA-approved indications, and aBLA and 505(b)(2) applications is obtained from public sources including the U.S. FDA website ( Information relating to litigations is given only for cases active from January 31, 2010 onward. Information relating to foreign biosimilar / biologics follow-on products approved in Australia, Canada, the E.U., Japan and South Korea is from public sources. Statistics graphics are compiled from information contained in the Venable BiologicsHQ database.


    The individuals who maintain this site work for Venable LLP. The information, comments and links posted on this site do not constitute legal advice. No attorney-client relationship has been or will be formed by any communication(s) to, from or with the site and/or the author. For legal advice, contact an attorney at Venable LLP or an attorney actively practicing in your jurisdiction. Do not send any confidential or privileged information to the author; neither Venable LLP nor the author will assume any liability or responsibility for it. If you send any information, documents or materials to the site, you give permission for the author to include them on or in the site. No information, documents or materials you send to the site will be considered confidential or privileged by Venable LLP or its lawyers. Also, no such information, documents or materials will be returned to you. All decisions relating to the content belong to the author.

    Subscribe for Future Updates