Physician Views: Biosimilar naming conventions – what do physicians think?
What's in a name? A lot, according to biosimilar developers, who continue to advocate that biosimilar products should share an international non-proprietary name (INN) with the innovator brand that they are based on.
Biosimilar launches in Europe have typically followed this approach, but it is in the US where the debate is most heavily focused at present. Furthermore, the administration is expected to unveil guidance this year about its proposed guidance for 'interchangeability' - an opportunity for biosimilar developers where naming conventions look to be particularly important.
With identical – and not 'similar' – INN designation seen as a potential catalyst to boost uptake of biosimilars, it is no great surprise to see US payers fighting in the same corner as biosimilar developers.
Innovator companies, in contrast, suggest that such an initiative would put patient safety at risk and limit the ability to track treatment usage effectively. One suggestion – put forward by the pro-identical INN lobby – is that advances in analytical tools make such arguments redundant by providing sufficient assurance that minor manufacturing changes will have insignificant clinical effect. Furthermore, traditional generics use the same INN as the branded originator and usage tracking works effectively with this system, advocates add.
But what do physicians think? What do they consider to be the correct naming convention and how will this impact their potential usage of biosimilars.
This week's Physician Views poll will ask US and EU5-based oncologists and rheumatologists:
Biosimilar launches in Europe have typically followed this approach, but it is in the US where the debate is most heavily focused at present. Furthermore, the administration is expected to unveil guidance this year about its proposed guidance for 'interchangeability' - an opportunity for biosimilar developers where naming conventions look to be particularly important.
With identical – and not 'similar' – INN designation seen as a potential catalyst to boost uptake of biosimilars, it is no great surprise to see US payers fighting in the same corner as biosimilar developers.
Innovator companies, in contrast, suggest that such an initiative would put patient safety at risk and limit the ability to track treatment usage effectively. One suggestion – put forward by the pro-identical INN lobby – is that advances in analytical tools make such arguments redundant by providing sufficient assurance that minor manufacturing changes will have insignificant clinical effect. Furthermore, traditional generics use the same INN as the branded originator and usage tracking works effectively with this system, advocates add.
But what do physicians think? What do they consider to be the correct naming convention and how will this impact their potential usage of biosimilars.
This week's Physician Views poll will ask US and EU5-based oncologists and rheumatologists:
- What naming convention for biosimilar products they believe would offer the most suitable option?
- What concerns they have/would have assuming a biosimilar shares an identical INN with the branded originator?
- The impact of an identical INN on originator-to-biosimilar switching?
- How important use of the INN is in their usage of biologic therapies?
- Which labelling convention would most likely encourage their prescription of a biosimilar?
