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Novartis Group calls on FDA to maintain the well-established naming policy for all biologics to help ensure patient safety
Date:10/30/2013

BASEL, Switzerland, Oct. 30, 2013 /PRNewswire/ -- Novartis announced today it has filed a Citizen Petition with the U.S. Food and Drug Administration (FDA), urging the Agency to require that a biosimilar share the same INN as the reference product.

Novartis argues that changing the well-established convention that the INN describes the active ingredient would undermine the safe and rational use of all biologics. In its petition, the company also highlights 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."

The main 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 e
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