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Biosimilars Forum Issues Comments on Proposed Rule for Designation of Official Names and Proper Names for Certain Biological Products

WASHINGTON, DC, (November 12, 2015) - The Biosimilars Forum today issued comments in response to a proposed rule released by the Food and Drug Administration, (FDA) to designate official names and proper names for certain biological products. [See the proposed rule issued in August.]

The following is a summary of the Biosimilars Forum’s general comments to the proposed rule. Read the Forum’s complete comments.

General Comments to the Proposed Rule

The Biosimilars Forum applauds the FDA for advancing an approach in this proposed rule and the related draft guidance document that recognizes each biosimilar is a unique, single source drug and that the naming convention applied to biosimilars must be applied equally to all other biological products in order to create a level playing field. However, the Forum has concerns about the proposal to use a random 4 letter identifier, rather than a meaningful suffix.

As noted in its comments on the draft guidance, the Biosimilars Forum takes no position on whether a suffix should be included in the U.S. proper name, but believes that if implemented as proposed for these six products, the FDA should allow for a meaningful suffix that is unique to the original product license holder, and that will be affixed to all biological products developed by that license holder. Accordingly, to the extent these six products will act as a model for biologic product proper names going forward, the Forum believes that the suffixes should be meaningful (preferably based on the name of the license holder), rather than random, as currently proposed.

In August, the Forum commended the FDA for issuing this proposed rule to designate official names and proper names for certain biological products as well as a previous submission on Nonproprietary Naming of Biological Products. These are important steps in helping to clarify policy issues related to biosimilars. Read the Forum’s comments to the previous submission specific to Nonproprietary Naming of Biological Products.

As the Biosimilars Forum comments state, a meaningful suffix would decrease the likelihood of transcription errors, medication errors and unplanned substitution of products. This will in turn increase patient and physician confidence in biosimilars which is the Biosimilars Forum’s hope for this new industry.

About the Biosimilars Forum

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.

To learn more about biosimilars, the Forum, and how to get involved, visit or go to @USBiosimilars to follow related conversations and join the dialogue.

Aimee Steel

Lynn Blenkhorn


Thursday, November 12, 2015