Novartis is latest company to side for naming biosimilars consistent with current standards for international non-proprietary names (INNs). This is consistent with the stance taken by other biosimilar backers GPhA and Hospira. It is counter to the position taken by other innovator drug companies and their lobbies -- PhRMA and BIO -- who want to see distinct names given to new biosimilar drugs. Novartis says this is confusing and will only go to slow down biosimilar adoption (the real agenda of innovators). Novartis cites the following negatives for breaking with INN convention:
- Any change to the current naming convention would undermine consumer confidence in biosimilar products, as well as the system at large.
- Inconsistencies in naming would lead to medication and prescription errors, putting patients at risk.
- IPP names are designed to identify the active pharmaceutical agent, not to distinguish between individual products.
- With robust drug safety systems in place, there is no need to resort to name changes to differentiate products
So the debate continues and we all await word from the FDA as to what path they would recommend and/or implement. See Total BioPharma.
Posted by Bruce Lehr Nov 4th 2013.