Following the 58th Consultation, which was held in April 2014 [1], the draft BQ document was further modified, based upon extensive internal comment, and placed on the WHO website with a request for comment from external parties. Over 100 comments were submitted from a mix of organizations, institutes, individuals and companies.

The comments showed that regulators and ‘institutions’ were least in favour of the BQ, whilst industry, academic and collaborating centres were most in favour. ‘Other’ respondents (patient groups, pricing associations, user groups), which provided almost half of the comments received, were about two-thirds in favour. Pharmacist associations were generally not in favour, especially those in the US.

As a result of the comments, the WHO created a subgroup of INN experts to assess all comments in detail, many of which were very constructive, and to devise a way forward prior to the next Consultation.

A particular area of confusion identified by WHO was the role of the BQ, whether it is for prescribing or pharmacovigilance or other purposes. However, WHO believes that with the BQ being voluntary, as is the INN itself, it would be up to the user to decide how a BQ would be best used within a particular jurisdiction. There are countries that potentially do not need the BQ.

The Generic Pharmaceutical Association (GPhA), however, argued in its presentation given at the 59th Consultation on INN that ‘INN naming has been simple and intuitive and this should not be changed’, stating that the brand name is the distinguishing factor. They pointed to the example of Neupogen (originator filgrastim) and Nivestim (biosimilar filgrastim). These two products have unique brand names, unique packaging, unique lot numbers and the same INN (filgrastim) for the common active ingredient. GPhA could not see what added value the addition of a BQ would provide.

GPhA added that a four-letter code would be difficult to remember, stating that ‘if a modifier is to be used, the clearest format would be the Marketing Authorisation Holder’s (MAH) name’. WHO has previously proposed a four-letter code to be used as a BQ [1]. They also stated that any BQ scheme should be voluntary, should not be linked to the manufacturing site (as some drug substances are manufactured at multiple sites) and should apply to all biologicals retrospectively.

The European Generic medicines Association (EGA) agreed with GPhA, stating that ‘the proposed BQ should only be used where needed; where traceability works well, for example, in the EU, introducing another component would only lead to confusion’. EGA also agreed that any BQ should ‘be applicable to all biologicals and not just biosimilars, that it should be applied retroactively, be voluntary for regulatory agencies and not be linked to manufacturing site. The association also agreed that ‘the proposed four-letter code will not be easy to remember’ and also suggested using the company name. Finally, it stated that any BQ should be administered by the INN secretariat.

The US Food and Drug Administration (FDA) declined to comment. The agency stated that ‘as its processes regarding the development of policies regarding the naming of biosimilar products and interchangeable products is ongoing, it is premature for FDA to comment on any proposals’. The United States Pharmacopoeia* (USP) stated that it ‘will not directly use the proposed BQ but basically supports the concept’.

The Alliance for Safe Biologic Medicines (ASBM) on the other hand pointed to its survey, which had highlighted the ‘considerable misunderstanding amongst prescribers’ with respect to biosimilars. The survey showed that where biosimilars are used, less than a third of prescribers use both the brand name and the INN and less than quarter use the INN only, leading ASBM to conclude that a unique identifier will therefore be important.  ASBM further stated that ‘a system that works globally will enhance patient safety and … is fully supportive of the BQ proposal’.

WHO concluded that ‘with the level of support for a BQ being at least half of the respondents it seems that the subgroup of INN experts could develop a potentially useable BQ’.

The 60th INN Consultation took place at WHO, Geneva, Switzerland, on 13–15 April 2015.

*USP is a scientific non-profit organization that sets standards for the identity, strength, quality and purity of medicines, food ingredients and dietary supplements manufactured, distributed and consumed worldwide.

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Reference
1.   GaBI Online - Generics and Biosimilars Initiative. WHO investigates use of a biological qualifier for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 27]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars

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