FDA rejects petitions over biologicals naming guideline

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FDA rejects petitions over biologicals naming guideline

INICIO/Directrices | Posted 17/02/2017 0 Post your comment

The US Food and Drug Administration (FDA) has rejected two citizen petitions urging the agency to allow biosimilar sponsors to use the same non-proprietary names as their reference products.

FDA issued the final version of its naming guidance, which detailed the agency’s requirements for the non-proprietary naming of biological products in January 2017 [1]. In the guidance, the agency sets forth a naming convention that gives biosimilars and their reference products distinguishable non-proprietary names.

The Generic Pharmaceutical Association (GPhA) and Novartis, with its generics division, Sandoz, had submitted separate petitions in September and October 2013, when FDA was still preparing its guideline. They argued that unique non-proprietary names for biosimilars could be detrimental to patient safety. The GPhA said the use of national drug codes would be more effective for tracking and pharmacovigilance. They also argued that ‘just as FDA does not require the nonproprietary name of a biological product to be changed to reflect product differences following a manufacturing process change, it is not necessary or appropriate to require distinguishing nonproprietary names for biosimilars’.

However, FDA announced in a 19 January 2017 letter that it was rejecting the petitions from the GPhA and Novartis. The agency argues that distinguishable names ‘will facilitate pharmacovigilance’ for all biologicals and help ‘track a specific dispensed product’, as well as ‘help minimize inadvertent substitution of any such products that have not been determined to be interchangeable’.

In response to the argument about manufacturing changes, FDA says that ‘in fact, these circumstances are quite different’, since it expects that a ‘biosimilar product will be created using cells of a different lineage than those used for its reference product’ and ‘using a different process’. In contrast, according to the agency, most manufacturing process changes ‘are small adjustments to one part of a highly defined process’.

FDA also argues that distinguishable names ‘would augment acceptance and uptake of biosimilars’ as they ‘will help healthcare providers and patients more readily and accurately identify and differentiate among biological products containing related drug substances’. The agency also clarifies that it has used non-meaningful suffixes in order to prevent confusion amongst healthcare providers and patients in cases where the licence holder’s identity changes. It adds that ‘suffixes that are devoid of meaning are potentially compatible with the ‘Biological Qualifier’ (BQ) scheme proposed by the World Health Organization (WHO)’.

Another petition submitted by Johnson & Johnson (J & J) in January 2014, which requested that biosimilars be assigned ‘nonproprietary names that are similar to, but distinguishable from, the nonproprietary names of their reference products or of other biosimilar products’, was granted.

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Reference
1. GaBI Online - Generics and Biosimilars Initiative. FDA issues final guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Feb 17]. Available from: www.gabionline.net/Guidelines/FDA-issues-final-guidance-on-naming-biologicals

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Source: US FDA