GPhA proposes using manufacturer names to distinguish biosimilars

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GPhA proposes using manufacturer names to distinguish biosimilars

Biosimilares/General | Posted 21/03/2014 0 Post your comment

The Generic Pharmaceutical Association (GPhA) has proposed a compromise naming scheme for biosimilars that it hopes will end the dispute over how to assign international non-proprietary names (INNs) to biosimilars in the US.

The GPhA, which represents the generics industry in the US, attended a meeting with the US Food and Drug Administration (FDA) on 9 January 2014 to allow the association to put forward their comments and views regarding non-proprietary names of biologicals.

The GPhA requested the meeting to discuss the dialogue held at a recent World Health Organization (WHO) meeting regarding non-proprietary names of biosimilars and the possible addition of identifiers to the INNs of originator biologicals in order to name biosimilars. The GPhA, in contrast, filed a citizen petition with FDA on 17 September 2013 recommending that ‘all biosimilars approved by the agency share the same INN as the biologic[al] products to which they refer’ [1].

FDA agreed to the meeting with the GPhA on the condition that it was a ‘listening session’, i.e. the FDA would be unable to answer questions or expand on any issues beyond what is in the public domain and what they have stated in the published draft guidance documents.

The GPhA, which represents the generics industry in the US, reiterated its position that it believes that adverse events can be traced back to the biological involved through the five data points it has outlined previously without the need to change the INN. However, at the WHO 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances, the use of a three-letter code or fantasy suffix to distinguish between biosimilars had been proposed [1].

The GPhA, however, pointed out that the random alphanumeric characters of the WHO/INN proposal would not function to directly identify the manufacturer. The association therefore proposed attaching the company name as a suffix to the INN without changing the INN as a way to distinguish between products. They also proposed that this then also apply to the originator product, e.g. filgrastim Amgen.

The GPhA believes that this proposal would provide ‘distinguishable’ and ‘immediate identification’. Although it still stood by its belief that any differences in name could still have an effect on patient safety, access and affordability of biologicals.

The GPhA also noted that in the Amgen comment on the GPhA and Novartis citizen petitions and in the recent citizen petition submitted by Johnson and Johnson (J&J), Amgen and J&J assert that the products should have ‘distinguishability’. The GPhA stated that it does not disagree with ‘distinguishability’, but believes that this can be done without changing the INN.

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Reference

1. GaBI Online - Generics and Biosimilars Initiative. Calls for biosimilars to have same INN at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 21]. Available from: www.gabionline.net/Biosimilars/General/Calls-for-biosimilars-to-have-same-INN-at-WHO-meeting

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Source: FDA