The Food and Drug Administration (FDA) has announced an information collection seeking sponsors of past and present biologic applications submit a proposed suffix composed of four lowercase letters for use as the distinguishing identifier included in the name designated by the FDA.
The information collection is pursuant to FDA biologics naming guidance issued in August 2015, “Guidance for Industry on Nonproprietary Naming of Biologic Products.” The guidance outlines the FDA’s intention for biologics to “designate a nonproprietary name that includes a core name and a distinguishing suffix,” this information collection seeks proposed four letter suffixes from sponsors of biological product applications.
The guidance included information collection by requesting that applicants propose a suffix composed of four lowercase letters for use as the distinguishing identifier included in the proper name designated by the FDA at the time of licensure for biological products licensed under the Public Health Service Act. The guidance recommended that applicants submit up to 10 proposed suffixes, in the order of the applicant’s preference, in addition to including supporting analyses demonstrating that the proposed suffixes met the factors described in the guidance.
The FDA estimated that they will receive a total of forty requests annually for the proposed proper name for biological products submitted under section 351(a) of the PHS Act, and 6 requests annually for the proposed proper name for biosimilar products and interchangeable products submitted under section 351(k) of the PHS Act.
Previous Response
There were a variety of responses submitted in response to an August 2015 Federal Register notice requesting public comment on the proposed collection of information. According to the FDA, most comments were supportive of the proposal to designate a suffix. Many suggested that a meaningful, distinguishable suffix may help to improve pharmacovigilance, enhance safety, and facilitate identification between biological products. Some comments supported the use of a random suffix to avoid creating an unfair advantage for specific manufacturers. One comment, however, noted that the FDA’s estimate of six hours to submit proposed suffixes, which was supposedly based on the FDA’s experience, is based only on the time needed to prepare the submission itself after multiple suffixes have been selected. The comment went on to note that because the FDA suggests that each respondent submit three suggested suffixes for consideration, the time needed to do an analysis of each suffix would exceed 720 hours per suffix or 2,160 hours total for the three suffixes, based on their own company experience.
The FDA believes those figures to be high and retain their original estimate of 6 hours, which is based on their familiarity with the average amount of time required by similar submissions to the FDA. The FDA does, however, revise their estimate upward to account for burdens associated with creating and submitting up to ten proposed suffixes for designation.
Industry Request and Opinion
This information collection follows a recent request by seventy different nonprofits and stakeholders, spearheaded by the Alliance for Safe Biologics, that the FDA use meaningful suffixes for biosimilar non-proprietary names, such as the one used with the first biosimilar approval for Zarxio. The group believes that meaningful suffixes are preferable to the random suffixes that are described in the aforementioned draft guidance, and what the agency used for its second approval for Inflectra.
The Alliance for Safe Biologics and other groups sent a letter to Leah Christi, Ph.D., associate director of therapeutic biologics and biosimilars at the FDA, saying, “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 group also noted that a survey of 400 biologic prescribers suggested they prefer meaningful suffixes over random by a six to one margin, while a survey of 401 United States pharmacists showed a preference for manufacturer-based suffixes over random.
The Biosimilars Forum, BIO and Pharmaceutical Research and Manufacturers of America (PhRMA) have also previously called for the FDA to use “meaningful” and “distinguishable” suffixes linked to the license holder’s name.
Comment Submission
Comments on the information collection are due thirty days following publication and may be submitted via fax or email to the Office of Information and Regulatory Affairs, OMB, Attn: FDA Desk Officer, FAX: (202) 395-7285, email: oira_submission@omb.eop.gov. All comments should be identified with the OMB control number 0910-NEW and title, “Nonproprietary Naming of Biological Products.” Docket No. FDA-2013-D-1543 should also be referenced.