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Novartis files Citizen Petition with FDA to maintain naming policy for all biologics to help ensure patient safety.
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: