Novartis has filed a Citizen Petition with FDA, advising the agency to require that a biosimilar share the same international nonproprietary name (INN) as the reference product. In the petition, the company argued that changing the established convention that the INN describes the active ingredient would undermine the safe and rational use of all biologics. The company also stated that "assigning different INNs to biosimilars would introduce unnecessary confusion into the healthcare system and could unintentionally communicate increased caution, unfounded risk, or other regulatory reservations that are purely hypothetical."
Key points addressed in the Novartis Citizen Petition include:
- INNs are not designed to identify a specific product or track adverse events. INNs were designed to indicate active pharmaceutical substances, not a specific product. They were also never intended to identify or track individual products; there is already a robust drug safety system in place, to report adverse events, for tracking and tracing. The current system identifies each biologic by brand names, National Drug Code (NDC) numbers, and manufacturer.
- Changing the naming convention would undermine FDA's years of practice in reviewing and approving manufacturing changes of originator biologics without requiring new INNs. Requiring separate INNs for biosimilars but not originator biologics would undermine FDA's own approval decisions, which in both cases require FDA to determine that the compared product produces the same effect as its comparator.
- An inconsistent application of naming conventions would lead to medication errors and jeopardize patient safety. Unique INNs for biosimilars would lead to confusion and encourage prescribing by INN. Current prescribing is by brand names with each brand name having been vetted for distinctiveness and clarity by FDA. FDA discourages the use of prefixes or suffixes in brand names because they are known to risk confusion and medication errors.