Changing Biosimilar Naming Rules Is A 'Delay Tactic:' Ramachandra Explains

Tomorrow, the World Health Organization will hold a closely watched meeting to sort out the debate over names for biosimilars. Specifically, the agency is being asked to determine whether the system that has been used for small molecule drugs – using the same international non-proprietary name , or INN, for both brand and generics – should be applied to biologics. Brand-name drugmakers and biotechs want to biosimilars to have unique non-proprietary, or generic, names to distinguish the medicines from the original biologics. In their view, distinct names would lessen confusion in the marketplace and, therefore, ensure patient safety. But generic drugmakers disagree and believe creating a new standard for biosimilars would, in fact, create confusion and have filed a citizen's petition with the FDA (back story). We spoke with Sumant Ramachandra, chief scientific officer at Hospira (HSP), which sells biosimilars in Europe, about the issue. This is an edited versions....  Pharmalot: So what is taking place at the meeting and what do you expect to result? Ramachandra: The WHO meetings is broader than just this issue, but a large chunk will be devoted to this issue... The purpose of this discussion, though, is around International Non-Proprietary Nomenclatures - the naming of drugs and how the WHO views them… The WHO is expected to at least reveal its preliminary position in terms of INN for biologics . The position is not just on biosimilars. It’s a key stakeholder meeting...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs