The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. This was followed by a draft proposal on naming biologicals, including biosimilars [1]. This has now been followed by the proposal to proceed with a provisional implementation of the BQ scheme accompanied by a prospective impact study.
WHO’s BQ would consist of a random alphabetic code, made up of four random consonants. The BQ code will be issued by an automated online system once a request is made by a BQ applicant. The established procedure for the selection of International Nonproprietary Names (INNs) will remain unchanged. Therefore, the BQ system would merely add a layer of naming to biologicals that is not used for small-molecule chemical drugs [1].
Following calls for its BQ system to be independently tested against the current system (trade name or INN + company) in order to ensure that it actually does improve identification and reduce safety risks, rather than causes confusion [2], WHO had originally planned to conduct a short study. But the body is now proposing that the BQ Working Group draw up terms of reference (TOR) for an impact study, which would be used to recruit a suitably qualified body, independent of industry and WHO, to gather data and report back annually to the INN group. The study would assess countries taking up the scheme, the number of BQs issued and how the database was accessed.
WHO is therefore proposing that the BQ be implemented on a provisional basis and that a prospective study is performed to enable evaluation of the impact of the BQ on access to medicines.
Medicines for Europe (previously the European Generic medicines Association), however, at the WHO’s INN meeting in Geneva in October 2016, questioned whether such a prospective approach ‘would provide sufficient data to evaluate the usefulness of the BQ for the intended purposes’. The group also questioned how the US Food and Drug Association (FDA) could be included in the pilot ‘since the FDA suffix is NOT equivalent to the WHO BQ’.
Other questions raised by Medicines for Europe included what are the criteria/key performance indicators for evaluating the impact on access to medicines within the scope of prospective implementation and how the added value of the BQ would be evaluated? They also propose that implementation of the proposed BQ scheme and the impact study be decoupled. They also state that ‘in particular in the interest of patients, it must be ensured that the BQ does not lead to any confusion or medical errors in the global health care arena’.
Medicines for Europe points out that ‘no single WHO Member Country has undertaken a formal and public regulatory impact analysis (RIA) regarding the WHO BQ scheme’. They therefore ‘urgently call for a moratorium of the provisional implementation of the BQ scheme and further international exchange and dialogue’.
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References
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 Oct 28]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier
2. GaBI Online - Generics and Biosimilars Initiative. Arguments for same INN for biosimilars presented at WHO meeting [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Oct 28]. Available from: www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting
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Source: Medicines for Europe, WHO
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