Novartis throws hat in biosimilar naming ring

Novartis AG (NYSE:NVS; SIX:NOVN) said FDA should use the same international non-proprietary name (INN) for both biosimilars and their reference biologic. In a Citizen's Petition to FDA, the pharma said using a unique INN for biosimilars would "introduce unnecessary confusion" that "could unintentionally communicate increased caution, unfounded risk, or other regulatory reservations that are purely hypothetical." Novartis also said INNs were never intended to identify and track individual products and that currently biologics are identified by brand names, national drug code numbers and manufacturer. The pharma also noted that FDA does not require an originator biologic to have a modified INN after approving manufacturing changes.

FDA has not announced a position on naming for biosimilars, but last week Rachel Sherman, director of the Office of Medical Policy in FDA's Center for Drug Evaluation and Research, said the agency's policy will be designed to ensure that products can be tracked and traced (see BioCentury, Sept. 30). ...