The FDA, in a new rule, draft guidance, and blog post, proposes distinct non-proprietary names for biologic and biosimilar drug products. The approach is anticipated to prevent unintended substitution of non-interchangeable therapies and will aid post-market tracking and monitoring. The guidance comes nearly six months after the FDA’s first biosimilar drug approval.
It’s proposed that randomly generated four-letter suffixes would be attached to biological medicines’ non-proprietary names. The proposed suffix should not be promotional, “such as by making misrepresentations with respect to safety or efficacy,” not include abbreviations commonly used in clinical practice and therefore subject to misinterpretation, not contain or suggest any drug substance name or core name, not look similar to the name of a currently marketed product or to any other product’s suffix.
The proposed naming system differs from the “placeholder” approach that the FDA used for approval of the first U.S. biosimilar, in which the four-letter suffix identified the biosimilar’s manufacturer.
How a biosimilar should be named has been one of the hottest issues since the enactment of BPCIA – which surprisingly, is silent on the matter. Supporters of unique non-proprietary names insist that they are necessary to ensure safety, accurate adverse event reporting and the preservation of physician and patient choice. On the other hand, advocates for use of the same name argue that the safety and pharmacovigilance concerns are minimal and that different names will be a major barrier to marketplace acceptance of biosimilars. In contrast, the European Union long ago decided that distinct names were necessary.
The FDA has not, however, is leaving the door open for a final definition. The proposal solicits public feedback on “the benefits and challenges of other naming approaches, such as a suffix derived from the name of the license holder.” The comment period on the draft guidance is open for 60 days, and the comment period on the proposed rule is open for 75 days.