On August 27, the U.S. Food and Drug Administration (FDA) released draft guidance calling for biological products to bear non-proprietary names that include a distinguishable suffix designated by the FDA. The Biologics Prescribers Collaborative (BPC) applauds the agency for recognizing that “there is a need to clearly identify biological products to improve pharmacovigilance, and, for the purposes of safe use, to clearly differentiate among biological products that have not been determined to be interchangeable.”
However, FDA guidance currently calls for “random” lettered suffixes to be assigned to each biological product, which is a departure from the provisional name it gave to Zarxio, the first biosimilar approved in the U.S. in March 2015.
Zarxio’s provisional name was filgrastim-sndz. The “sndz” denotes the manufacturer’s name – Sandoz. Under the current random suffix scheme, the new name would be filgrastim-bflm. The “bflm” is devoid of meaning. FDA has provided proposed suffixes for several other biologic products already on the market which are all comprised of random letters.
BPC believes that “meaningful” suffixes like “sndz” would help healthcare prescribers in the use of biologics as they would be more memorable, limit confusion and hold manufacturers accountable.
While distinguishable names are essential to ensure that any adverse events are attributed to the right biological products, names made distinguishable by the use of meaningful and intuitive suffixes will greatly enhance pharmacovigilance, patient safety and transparency.
**BPC requests that prescribers make their viewpoint on naming known to FDA, which is inviting comments to its guidances. Please find below resources and instructions on how to submit comments to the agency.
Resources
- FDA Nonproprietary Naming of Biological Products: Draft Guidance for Industry
- FDA Blog Post announcing draft guidance: Naming and Biologics Products
Submitting comments to the FDA
1. Proposed Naming Guidance:
FDA invites comment on the draft guidance, including potential approaches for designating and incorporating suffixes retrospectively and prospectively into the nonproprietary names of all biological products. FDA is also soliciting comments on ways to improve active pharmacovigilance systems for the purposes of monitoring the safety of biological products. Additionally, FDA is seeking comments on whether the nonproprietary name for an interchangeable product should include a unique suffix, or should share the same suffix as its reference product. See the below sites for proposed questions.
To submit comments:
- Visit this Federal Register page for the FDA draft guidance, submission instructions, proposed questions and additional information.
- Actual submissions should be submitted through Regulations.gov here.
- Submissions must be received by October 27, 2015 at 11:59pm ET.
2. Proposed biosimilar names:
FDA invites comment on the proposed official names and proper names for these products. In particular, FDA invites comment on 1) the benefits and challenges of designating a distinguishing suffix that is unique to each of these six biological products versus designating a distinguishing suffix that is shared by each product manufactured by a single license; 2) whether meaningful suffixes (e.g., suffixes derived from the names of the license holders) would be expected to be more memorable or useful to health care providers or patients than suffixes devoid of meaning and 3) on whether meaningful suffixes derived from the name of the license holder might create inappropriate market advantages that would impede biosimilar products’ acceptance in the market.
To submit comments:
- Visit this Federal Register page for FDA’s proposed rule, submission instructions, proposed questions and additional information.
- Actual submissions should be submitted through Regulations.gov here.
- Submissions must be received by November 12, 2015 at 11:59pm ET.