On January 12, 2017, FDA released its long-awaited final guidance on naming of biologics and biosimilars, entitled “Nonproprietary Naming of Biological Products.” According to FDA, the nonproprietary naming convention provided in the final guidance is intended to aid pharmacovigilance and to help prevent confusion and inadvertent substitution.
FDA’s newly-issued guidance covers the nonproprietary naming convention for originator biological products, related biological products, and biosimilar products. These products may have both a proprietary name established by the manufacturer (usually a trademark) and a non-proprietary (referred to by FDA as the “proper”) name. The proper name of a biologic is different from its proprietary name and reflects scientific characteristics of the product, e.g., chemical structure and pharmacological properties. FDA’s guidance document explains that “the proper name of a biological product helps health care providers identify the product’s drug substance and distinguish biological products from one another.”
Under the naming convention provided in the final guidance, “the nonproprietary name designated for each originator biological product, related biological product, and biosimilar product will be a proper name that is a combination of the core name and a distinguishing suffix.”
For originator biological products, FDA intends to use the name adopted by the USAN Council for the relevant biological substance as the core name when available. For related biological products and biosimilar products, the proper name will contain a combination of the core name, which is the same as that of the previously-licensed product, followed by a unique, lowercase, four-letter suffix designated by FDA and attached to the core name via hyphen. The guidance indicates that the proper name of interchangeable products will also use the same core name as the innovator product followed by a suffix, but FDA is still considering the appropriate suffix to be used for products designated as interchangeable.
The final guidance came more than a year after FDA first published a draft guidance on naming biologics in August 2015. In the draft guidance, FDA specifically asked for comments on the potential benefits and challenges of designating a suffix that is meaningful versus a suffix that is devoid of meaning. See “Nonproprietary Naming of Biological Products; Draft Guidance for Industry; Availability” Notice, 80 Fed. Reg. 52296 (Aug. 28, 2015). Industry response was mixed. Prior to issuance of the draft guidance, in September 2013, GPhA filed a Citizen’s Petition and submitted a letter to FDA signed by 32 organizations recommending that all biosimilars share the same international non-proprietary name as the biologic reference product. In November 2015, the Biosimilars Forum submitted comments in which it did not take a position on whether a suffix should be included in the U.S. proper name. However, in the event FDA elects to include a suffix, then the organization urged that the suffix should be affixed to all biological products developed by a particular company and should be meaningful, as opposed to random, preferably derived from the company name. In 2016, BIO and PhRMA submitted comments on the draft guidance and also jointly filed a Citizen’s Petition in favor of using a meaningful, distinguishing suffix.
FDA decided to require a distinguishing suffix, but declined to adopt a convention that attaches any significance or meaning. In particular, the final guidance provides that for all biological products, related biological products, and biosimilar products, the suffix should be “devoid of meaning.”
Interestingly, FDA intends to apply the naming convention retroactively to previously-licensed biological products as well as prospectively to newly-licensed products. For prospectively licensed products, FDA expects the applicant to propose up to 10 distinguishing suffixes, in the applicant’s order of preference, as part of the IND or BLA at the time of submission. FDA has provided specific factors for guidance in selecting proposed suffixes and recommends the applicant include any supporting analyses for FDA’s consideration based on those factors.
FDA is still considering the process for implementation of the naming convention to previously-licensed biological products. However, the guidance conveys that FDA intends for previously-licensed originator products, related biological products, and biosimilar products to receive a revised proper name with the product’s original proper name as the core and a distinguishing suffix added with a hyphen. FDA expects to assign distinguishing suffixes for a limited number of previously-approved licensed products and provides guidance to the holders of pending applications and previously-approved products for submitting proposed suffixes as a prior-approved labeling supplement. FDA may continue to use a prefix (along with a core name and a suffix) in some instances to distinguish related biologics from previously-licensed biological products (e.g., ado-trastuzumab emtansine-xxxx to distinguish over trastuzumab-xxxx).
The guidelines provide that the proposed suffix should be:
- devoid of meaning
- four lowercase letters of which at least three are distinct
- attached to the core name with a hyphen
- free of legal barriers that would restrict its usage
The guidelines further provide that the proposed suffix should not:
- be false or misleading, such as by making misrepresentations with respect to safety or efficacy
- include numerals and other symbols aside from the hyphen attaching the suffix to the core name
- include abbreviations commonly used in clinical practice in a manner that may lead the suffix to be misinterpreted as another element on the prescription or order
- contain or suggest any drug substance name or core name
- look similar to or be capable of being mistaken for the name of a currently marketed product (e.g., should not increase the risk of confusion or medical errors with the product and/or other products in the clinical setting)
- look similar to or otherwise connote the name of the license holder
- be too similar to any other FDA-designated nonproprietary name suffix
Further, FDA encourages applicants to conduct due diligence on proposed suffixes to avoid any other prohibitions or restriction on use. The final determination regarding acceptability of a proposed suffix will be based on FDA’s review of any information submitted by the sponsor and all information and analyses described in the guidance.
You can read the full Guidance document here.