WHO issues draft proposal for its biological qualifier

Home/Policies & Legislation | Posted 07/08/2015 post-comment0 Post your comment

The World Health Organization (WHO) first introduced the concept of a biological qualifier (BQ) for naming biologicals back in 2014. Now the body has issued a draft proposal covering the issue of how to name biologicals, including biosimilars.

Naming 1 V13I27

The proposal suggests that the BQ would be used in conjunction with the International Nonproporietary Name (INN) and 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 WHO reiterates that the established procedure for the selection of 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.

The scheme will be overseen by the WHO INN Expert Group and administered by the WHO INN Secretariat and will be paid for by a single fee for each application.

Although WHO says that it has made this proposal upon request of regulatory authorities around the world, not everybody agrees with the WHO’s approach to naming. The Generic Pharmaceuticals Association (GPhA) has previously pointed out that Europe has approved biosimilars with the same non-proprietary names as their reference biologicals for more than six years in a system that has proved effective. Biosimilars have also been successfully tracked in the marketplace using their brand name and other identifiers currently in place for product recognition, meaning a separate non-proprietary name [or BQ] is not necessary for keeping track of biosimilars once they are on the market.

Others have also called for any new 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 cause confusion [1].

WHO believes advantages of the system to include allowing doctors to identify issues associated with patients’ responses to different products containing substances with the same INN. While it says the BQ will allow patients to identify what biological medicines to use when residing or visiting foreign countries.

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WHO investigates use of a biological qualifier for biosimilars

1. 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 2015 Aug 7]. Available from: http://www.gabionline.net/Biosimilars/General/Arguments-for-same-INN-for-biosimilars-presented-at-WHO-meeting

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Source: WHO

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