Senators To FDA: Has Biosimliar Naming Policy Changed?

In the latest dust up over naming biosimilars, a bi-partisan group of US Senators today is sending a letter to the FDA to demand the agency explain why a seven-year-old policy toward determining names has gone missing from its web site. And their missive, which questions whether agency policy has changed, arrives as a contentious debate over naming these medications intensifies on both sides of the Atlantic. Yesterday, the World Health Organization held a widely anticipated meeting in Geneva to begin a review of the naming issue. And last month, the trade group for generic drugmakers in the US filed a citizen’s petition with the FDA to request that all biosimilars share the same international non-proprietary name (INN) as the reference drugs, or original biologics (back story). As we have noted previously, brand-name drugmakers and biotechs want the FDA to ensure that every biosimilar has a unique non-proprietary, or generic, name that will distinguish the medicine from the original biologic. In their view, distinct names would lessen confusion in the marketplace and, therefore, ensure patient safety and are lobbying the WHO to change its guidelines (read here and here). But generic drugmakers argue that the same policy that governs nomenclature for existing medicines should also apply to biosimilars and would change the current system that is used for drugs globally would confuse physicians. They also argue the bid for separate names is a "delaying tactic” designed to th...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs