WHO proposal offers clarity for biosimilar nomenclature

Following requests from drug regulatory authorities worldwide, the World Health Organization (WHO) has released a draft Biological Qualifier (BQ) proposal on which to base a globally recognized naming scheme for biological products, including biosimilars. According to the proposal, a four-letter code – the BQ – would be added after the INN.

The recommendation, from the International Nonproprietary Names (INN) expert group of the WHO, [1] follows extensive discussion on the naming of biosimilars [2-4], and is intended to halt the proliferation of different names and nomenclature policies in different countries.

Unlike generic medicines, biological products may be similar but – because of their structural complexity – cannot be identical. This has led to a lack of uniformity in the naming of biosimilars. An internationally recognized system for recording where a drug was made seeks to restore order.

The proposed BQ is an alphabetic code assigned at random to a biological active substance manufactured at a specified site. The choice of letters making up each code will be made to facilitate transliteration into various languages and to avoid meaningful or inappropriate words being used. The use of four letters, excluding vowels, offers more than 160,000 codes, which should be sufficient for the foreseeable future.

The coding would apply to all biological active substances to which INNs are assigned and would be applicable retrospectively. The INN will not be affected by this, as was made clear in the 57th Consultation on International Nonproprietary Names for Pharmaceutical Substances [4]. The BQ code will not be part of the INN.

Application for BQ codes will be made to the WHO INN Secretariat at the time of submission of a marketing authorization application to a regulatory authority, by the prospective marketing authorization holder. A fee for each application is payable so that the scheme is self-funding.
Participation in the BQ system by national regulatory authorities (NRAs) will be voluntary, but all NRAs will have access to the manufacturing location and regulatory history for any product assigned a BQ.

BQ codes are intended as unique identifiers of the active substance from a given source. The INN expert group concludes that the BQ scheme will be used by, and useful for, regulatory authorities, health authorities, pharmacists, physicians, healthcare workers, and patients.

Written comments proposing modifications to the text in the draft proposal must be received by 19 September 2014 by the WHO Department of Essential Medicines and Health Products (EMP).

Readers interested to learn more about the discussion on the biosimilars naming discussion in the US are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal in 2014:

References
1. World Health Organization. Biological Qualifier. An INN Proposal. Draft. July 2014 [homepage on the Internet]. 2014 Jul 30 [cited 2014 Aug 14].
2. 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 Aug 14]. Available from: www.gabionline.net/Biosimilars/General/Calls-for-biosimilars-to-have-same-INN-at-WHO-meeting
3. GaBI Online - Generics and Biosimilars Initiative. EU majority says same INNs for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/General/EU-majority-says-same-INNs-for-biosimilars
4. 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 2014 Aug 14]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars

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Source: WHO

Posted 15/08/2014 by Ronald A. Rader

Comments on INN/WHO Biologics Qualifiers

THIS PROPOSAL IS INCOHERENT AND UNCLEAR, AND HAS INN/WHO DOING THINGS IT HAS NO BUSINESS DOING! A few key points derived from this follow:

INNs (which I assert are just too incoherent and inappropriate as names for biopharmaceuticals, including being neither generic nor unique enough) are proposed to optionally be a little less generic by appending a 4-letter code for manufacturing site (and implicitly, the manufacturer). However, reading the proposal, it is totally unclear what BQs are being based on, assigned to and how they will be used!

The proposal jumps all over the place, proposing implementing INN BQ site modifier codes not just for registration of biopharmaceutical API manufacturing sites, but also registration of specific biopharmaceutical APIs (with granting of an INN BQ interpreted as a de facto approval?), registration of API-containing finished products too (to be construed as approvals?), and tracking of all related countries’ related product approvals, including supplemental approvals, worldwide. Plus, the proposal sets up a new user fee self-perpetuating WHO bureaucracy to do this. There are a lot of unstated, unexplained links and technically just strange jumps in logical connections being made between facilities (BQs, presumably), APIs, finished products and product approvals. WHO seems (it remains unclear) intent on using INN BQs to imply or codify such things as: APIs with the same assigned INN BQ are "biosimilar," the same and/or interchangeable and; finished products containing the same INN BQ-identifed API are "biosimilar" same and/or interchangeable. Also, seemingly much or most site data may not be disclosed; the same API-based INN BQs will often apply to multiple products; and products will often have multiple INN BQs, with these issues along making INN BQs useless or worse for real-world use (unless the BQs are made so generic as to not be informative about manufacturing sites, companies, APIs, products, or whatever they are intended to track).