What's In A Name? Novartis Petitions FDA Over Biosimilar Nomenclatures

The mushrooming dispute over the sort of name that should be given to biosimilars gets more interesting all the time. Earlier this week, Novartis filed a petition with the FDA and requested that all such products share the same international non-proprietary name (INN) as the reference drugs, or original biologics.   In its 23-page petition, Novartis writes 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 drugmaker also argues that imposing unique INNs would not improve patient safety or pharmacovigilance (here is the petition). In doing so, the drugmaker sided with the Generic Pharmaceutical Association, which filed a petition of its own last month to make the same request (back story). Of course, Novartis owns Sandoz, which is one of the biggest generic drugmakers in the world and the move can be seen as a bid to defend the potential for the unit to generate needed revenue that can later fund research into new medicines. Several years ago, in fact, former Novartis (NVS) chairman and ceo Dan Vasella noted that biosimilars are not incompatible with original biologics from a strategic point of view. He argued that an innovative drugmaker needs biosimilars to help fund the next generation of products. "You need this push in order to have the innovation," an industry source fa...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs