WHO Releases New Draft Proposal for Assignment of Biological Qualifiers

Approved Biosimilar Products  •  Biosimilar News

In a move that may impact the continuing debate over how to name and label biosimilar biologics, the World Health Organization (“WHO”) has released a new draft of its proposal for assignment of Biological Qualifiers (“BQ”).  The BQ proposal aims to standardize naming of biologics by giving each approved and marketed biological active substance an alphabetic code assigned at random, eliminating some of the confusion that is present in the current International Nonproprietary Names (INN) scheme.  The code will consist of four consonants, and will be used to uniquely identify biologics.  The BQ system will supplement the existing INN scheme, which provides unique names to active substances used as pharmaceuticals.

Biological substances currently comprise 40% (and rising) of the applications to the INN.  Due to the complexity of biological products, several problems have arisen with the INN system, which the BQ system seeks to remedy.  For small molecules and non-glycosylated proteins, the structure, and hence the INN, of the originator will be the same as of the generic.  However, for glycosylated proteins, differences in glycoform profiles may arise between the originator and the generic.  The INN deals with this by assigning a Greek letter (e.g., epoetin lambda) after the INN name.  However, because participation in the INN scheme is voluntary, it was assumed that and INN request for a glycoprotein that already has an INN would imply a difference in glycoform profiles, when this was not always the case.  Furthermore, in the past some countries had issued INN-like names, without officially going through the INN.  Therefore, the BQ system was developed to assign names prospectively and retrospectively to all biological substances assigned INNs, that could be adopted voluntarily by any regulatory authority.

The current draft provides clarification over the earlier July 2014 draft.  For example, the June 2015 draft provides further information about when the BQ system might be used: “It is proposed that the BQ is issued for all drug substances of biological medicines including biosimilars, innovator products, non-glycosylated and glycosylated proteins. The only exceptions will be vaccines, impure mixtures and complex biologically-extracted products like heparin or pancreatin to which INNs are not assigned.”

Some explanatory language has also been added.  The June draft now provides that:

Some regulatory authorities have made the decision that the use of trade name and INN are adequate for prescription and dispensing and that trade name, INN, MAH name and batch number are adequate for pharmacovigilance in conjunction with other tracking systems such as 2D barcoding. The use of the BQ offers a means (a) which uniquely identifies the drug substance even if used alone and/or (b) of crosschecking other information supplied in a prescription/dispensing or pharmacovigilance setting, in the absence of other sophisticated tracking systems.

The new draft also provides insight on who might be applying for a BQ, and contains helpful reference tables on the type of information that might be used for BQ naming in different countries.

One potential problem identified by the WHO is that a situation may arise where two different regulatory authorities may make different determinations about whether glycosylation in a glycosylated protein is comparable – thus leading to two regulatory authorities assigning different Greek INN letters and thus different BQs.  However, this situation is “likely to be rare and hyperlinks between the two database entries would be introduced.”

Overall, the aim of the BQ proposal and the methodology by which it will be implemented is unchanged from the July 2014 draft.

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