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# Comments on Nonproprietary Biologic Naming
- URL: https://www.fdaweb.com/comments-on-nonproprietary-biologic-naming/
- Published: 2019-05-08T12:00:00.000Z
- Updated: 2026-09-15T01:25:24.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5144063

The Biotechnology Innovation Organization (BIO) says it is pleased that FDA has included in a draft guidance on nonproprietary naming of biological products use of a four-letter distinguishable suffix for biological products. “BIO shares FDA’s view that a distinguishable nonproprietary naming convention will best facilitate robust pharmacovigilance, promote accurate attribution of adverse events to the correct product, mitigate the risk of inappropriate or unintended substitution and unintended switching, and support unique product identification, which will help to ensure targeted regulatory action, should the need arise,” the association comment [letter](https://www.regulations.gov/document?D=FDA-2013-D-1543-0220&ref=fdaweb.com) says. BIO also says that it is essential that suffixes be memorable to allow healthcare practitioners to understand the distinct identity of each product and to enable pharmacovigilance. Thus it recommends that the suffix for a biological product be unique to each license holder and that license holders be afforded the option of using the same suffix for each biological product from that license holder.

The United States Pharmacopeia (USP) [says](https://www.regulations.gov/document?D=FDA-2013-D-1543-0221&ref=fdaweb.com) it supports FDA’s revised application of the naming convention for biological products licensed without a suffix and transition biological products, that such product names will not need to include a proper name that is a combination of the core name and an FDA-designated suffix. “USP remains concerned that the naming convention will apply to new biological products, including interchangeable products, as this may have unintended consequences,” the comment says.

In its [letter](https://www.regulations.gov/document?D=FDA-2013-D-1543-0223&ref=fdaweb.com), Pfizer suggests that application of the naming convention to both biosimilars and their reference products may increase the likelihood of awareness and utilization of the suffixes in adverse event reporting. The company also says that application of the naming paradigm to biosimilar and interchangeable biological products but not their reference products, with the stated objective of pharmacovigilance and safe use, creates a perceived difference and disingenuous exploitation of this perception could undermine the biosimilars pathway. And it expresses concern that failure to apply the naming convention to reference biological products that were licensed without an FDA-designated suffix in their proper names could have unintended consequences on market uptake due to prescribing practices. Pfizer joins BIO in recommending that the suffixes be related to the license holders to make them more memorable.