Dr. Suhasini Sharma

Safety & Risk Management for Biosimilars : Biosimilar Naming

Dr. Suhasini Sharma

Naming can have important implications for traceability/identification and safety monitoring for biosimilar products. This is currently a hotly debated topic across the biopharmaceutical industry. While some have advocated assigning unique nonproprietary names to biosimilars, there is an equally strong viewpoint on using the WHO assigned International Nonproprietary names (INNs) in order to have a comprehensive database of information related to products with the same biological active ingredient. In Europe, biosimilars share the same INN with their reference products, and each individual product is identified by a brand name. Australia’s Therapeutic Goods Administration (TGA), in their Guidance dated July 2013, proposed that a biosimilar would use Australian biological name (ABN) of the reference product + a biosimilar identifier, consisting of the prefix sim* and a three letter code issued by the WHO INN Committee (For e.g. – infliximab simfam).

Though the US FDA is yet to release their guidance on biosimilar naming, the first approved biosimilar in the US is identified as filgrastim-sndz (ZARXIO). On May 20, 2015, experts from the FDA and some of the prominent biological product companies met under the aegis of the Alliance for Health Reform to discuss challenges related to biosimilars. They felt that the use of different (unique) nonproprietary names for biosimilars will add complexity to the PV process for biological actives, and supported the use of the same INNs as those for the reference products.

In order to curb the different naming systems in existence today, the World Health Organization (WHO) – INN, through a draft policy released in July 2014, proposed a biological qualifier (BQ) system that would involve tagging a biosimilar with a random alphabetic code to represent a biologically active substance manufactured at a specific site. This would complement the use of INN. In view of this, in January 2015, Australia’s TGA announced that their previously proposed naming policy will be kept in abeyance till a final decision is reached on naming, and in the interim, biosimilar products would use TRADENAME+ABN.

The proposed WHO BQ naming system is not without its critics though. A number of flaws in the proposed system have been pointed out by the stakeholders. The European Biosimilar Group (EBG), part of the European Generics Group (EGA), thinks that the complex naming system proposed by the WHO is in fact, likely to impact adverse event monitoring as reporting physicians and patients may leave out some part of the information while reporting. Further, other concerns raised are “how would the random alphabet sequence be generated? Would there be any mix-ups between similar sounding sequences resulting in medication errors? Would the same BQ apply to all products manufactured at the same site?” These are genuine concerns and till these are satisfactorily addressed, a naming policy with either a unique Trade name (INN) or INN+ company name seems to be workable solution for biosimilars from the point of view of traceability & product identification.