IGBA opposes WHO biological qualifier

Biosimilares/General | Posted 25/03/2016 post-comment0 Post your comment

The World Health Organization (WHO) is considering a proposal to assign Biological Qualifiers (BQs), which are random alphabetic codes, to help standardize the naming of biologicals, including biosimilars [1]. However, not everyone agrees with their proposal.


The International Generic and Biosimilar medicines Association (IGBA), while saying that it welcomes the WHO’s continuous interest in the development of a global identification system for biologicals, has issued a press release stating that the ‘IGBA does not support the BQ proposal’. The IGBA says that ‘successful product identification and tracking using multiple identification components are already in force’. The association points to use of the brand name or the international non-proprietary name (INN) combined with the company name, the lot number and various national codes.

The IGBA is concerned that the proposal is ‘meaningless, unmemorable, confusing [and] unnecessarily complicated’. It also believes that retrospective application of BQs to already authorized products may lead to discrimination and be anticompetitive.

The IGBA is therefore calling on WHO to make fully transparent all the positions on the BQ during the consultation periods, in particular those of the drug regulatory authorities requesting action by WHO. It is also calling on WHO to urgently extend the timelines for the final report by a minimum of six months to allow a proper international impact assessment, saying that the current timelines ‘can hardly allow for a comprehensive and meaningful impact assessment on all the various international stakeholders and areas potentially affected by the proposed identifier’.

On 2 March 2016, the Generic Pharmaceutical Association (GPhA) and its Biosimilars Council joined the IGBA in opposing the BQ and in saying that the ‘WHO will need more time to properly assess the global implications of its BQ proposal’.

The GPhA’s Biosimilars Council went on to state that ‘tracking and safety concerns have long been addressed by the inclusion on the label of the brand name, company name, national drug code (NDC) and lot number, thus, eliminating the need for unnecessarily complicated and confusing suffixes or checksums – there is no compelling reason to add additional identifiers for biosimilar drugs’.

This is a view that has also been expressed by other groups, such as the European Generic medicines Association’s (which recently became Medicines for Europe) European Biosimilars Group (EBG). The EBG’s Summary position regarding the WHO Biologic Qualifier Proposal, which was issued on 21 March 2016, states that:

‘No additional component is needed in most jurisdictions as they manage very well with the brand name or INN accompanied company name; the BQ should NOT be implemented in these countries, including the European Union (EU) since identification of biologicals is ensured and a number of legal tools and measures are in place. In any case, introducing a new identifier into the EU would require a legislative change.’

Related articles
FDA issues draft guidance on naming biologicals

ACR position statement on biosimilars addresses naming and substitution

Australia reviewing plans for naming biosimilars

Source: GPhA, IGBA, Medicines for Europe

1. GaBI Online - Generics and Biosimilars Initiative. WHO issues draft proposal for its biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Mar 25]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier

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