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# FDA Moving Forward on Final Guide for Biosimilar Naming
- URL: https://www.fdaweb.com/fda-moving-forward-on-final-guide-for-biosimilar-naming/
- Published: 2016-06-01T12:00:00.000Z
- Updated: 2026-09-14T21:06:36.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135812

FDA has asked the Office of Management and Budget to approve an information request outlined in a 2015 draft guidance on *Nonproprietary Naming of Biological Products* that would have biologic and biosimilar product sponsors submitting proposed suffixes to be incorporated in the nonproprietary name on such products ([see story](http://fdaweb.com/login.php?sa=v&aid=D5133146&searchWords=suffix&cate=S&stid=%241%24gr3.pK%2F.%24ghRV6oK.49zSY8T22U2lq0&ref=fdaweb.com)). According to an [FDA notice](https://s3.amazonaws.com/public-inspection.federalregister.gov/2016-12885.pdf?ref=fdaweb.com) on the guidance, applicants should submit up to 10 proposed suffixes, in the order of the applicant’s preference. It also recommends including supporting analyses demonstrating that the proposed suffixes meet the factors described in the guidance for FDA’s consideration.

OMB approval is the next step in the guidance process. An FDA spokesman told ***FDA Webview*** that final guidance is “forthcoming,” but no specifics on the timing were provided.

The notice also highlighted some of the comments FDA has received on the draft guidance. For example, it said many comments suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. This echoes recommendations outlined in a [letter](http://safebiologics.org/wp-content/uploads/2016/05/FDA-Patient-Naming-Letter-5-2.pdf?ref=fdaweb.com) to the agency from a 70-group coalition of healthcare stakeholders, including patient and provider organizations. The groups said that by FDA “instituting a distinguishable naming system for biological medicines that incorporates meaningful, memorable suffixes,” it will achieve strong patient protections, critical transparency and promote pharmacovigilance, resulting in greater prescriber confidence. “Meaningful suffixes are easier for patients, providers and pharmacists to both recognize and remember, thus facilitating accurate association between adverse events and specific products,” the letter said. “A suffix based on the manufacturer name, as was used in the Zarxio approval where ‘-sndz’ refers to ‘Sandoz,’ also promotes manufacturer accountability.” The groups opposed random suffixes described in the FDA’s draft guidance and used in its second approval for Inflectra (infliximab-dyyb).

Additionally, FDA said that some comments supported use of a random suffix to avoid creating an unfair advantage for some manufacturers. And several comments stated that the current practices of FDA and non-FDA entities for identifying biosimilar and interchangeable products is sufficient for the purpose of pharmacovigilance, and designation of a suffix is not needed.