Naming and labelling of biosimilars has been a controversial issue and there is a long-standing debate regarding the naming of biologicals.
The different approaches to naming and labelling of biosimilars used in different countries around the world was investigated in a survey carried out by the World Health Organization (WHO) in 2019–2020 [1]. The survey found that most of the countries surveyed did not have specific regulations/guidelines relating to the naming and labelling of biologicals/biosimilars. Countries that do have specific regulations/guidelines include Canada, China, Japan and Iran.
Canada established its naming policy in 2019 in its Notice to Stakeholders – Policy Statement on the Naming of Biologic Drugs. In the guidance it states that biological drugs, including biosimilars, will be identified by their unique brand name and non-proprietary (common) name, without the addition of a product-specific suffix [2]. The naming criterion for biologicals in China is fully implemented (Supplementary volume I of The Pharmacopoeia of the People’s Republic of China 2015 Edition). The Chinese regulatory authority also prepared draft guidance on naming biosimilars in 2018, but this has not yet been officially adopted. Japan finalized nomenclature rules in 2013. Regulations in Japan require that biosimilars of complex protein products bear unique non-proprietary names. The naming convention requires the biosimilar to use the non-proprietary name of the reference product, plus ‘biosimilar’ or ‘BS’ and a number indicating the order in which the biosimilar was approved in Japan, e.g. bevacizumab BS1 [3]. Iran adopted a regulation for naming of pharmaceutical products in 2013.
The survey revealed that many countries use the brand name and International Nonproprietary Name (INN) without any other distinguisher.
In the European Union, both the brand name and INN are used to identify the specific biological product, whether it is an originator biological or biosimilar. 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 been successfully tracked in the marketplace using their brand name and other identifiers, e.g. batch numbers, currently in place for product recognition. European regulators have reported 96.2% product identification across three product classes (filgrastim, epoetin, somatropin) [4].
Japan, Malaysia, Peru and Thailand have a distinguisher (identifier), that is, product‐specific suffix, as part of the name. Japan’s policy includes the INN of the reference product, with a biosimilar qualifier (‘BS’) and a code for the order of approval, e.g. bevacizumab BS1 [3]. Malaysia has the statement ‘biosimilar product’ on the label and prescribing information, and Peru includes the statement ‘similar biological product’ in the summary of product characteristics. Thailand uses the letter code ‘NBS’ followed by sequential numbering.
The South African naming convention policy requires that the holder of the certificate of registration ‘is responsible for ensuring that the product is traceable, i.e. reflection of the proprietary name of the product on the adverse event reports’. Australia’s drug regulatory agency, the Therapeutic Goods Administration, had previously proposed that all biosimilars in Australia have distinguishable names, but is now reviewing its policy following recent international developments in the area of biosimilar naming’ [4].
In the US, the Food and Drug Administration (FDA) has also issued guidance on naming biosimilars. This requires that all biologicals and biosimilars have non-proprietary names and that a 4-letter suffix be added to the names to distinguish them from each other. The suffix is composed of four lowercase letters and does not carry any meaning. For example, the non-proprietary name of a reference product could be replicamab-cznm and a biosimilar to that product could be replicamab-hixf [5].
Back in 2014, WHO introduced the concept of a biological qualifier (BQ) for naming biologicals. WHO has issued a draft proposal, which suggests that the BQ would be used in conjunction with the INN and would consist of a random alphabetic code made up of four random consonants [6].
The authors conclude that ‘naming and labelling are both very important for the identification of products and also for pharmacovigilance and prescribing. Good pharmacovigilance is essential for establishing the safety and efficacy of interchangeability of biosimilars’.
Conflict of interest
The authors of the research paper [1] declared that there was no conflict of interest.
Editor’s comment
Readers interested to learn more about naming of biologicals and biosimilars are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
The need for distinct nomenclature for originator and biosimilar products
Product naming, pricing, and market uptake of biosimilars
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References
1. Kang HN, Thorpe R, Knezevic I, et al. Regulatory challenges with biosimilars: an update from 20 countries. Ann N Y Acad Sci. 2020 Nov 21. doi: 10.1111/nyas.14522. Epub ahead of print.
2. GaBI Online - Generics and Biosimilars Initiative. Health Canada announces naming convention for biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Policies-Legislation/Health-Canada-announces-naming-convention-for-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Naming and interchangeability for biosimilars in Japan [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Reports/Naming-and-interchangeability-for-biosimilars-in-Japan
4. GaBI Online - Generics and Biosimilars Initiative. Biosimilar naming conventions around the world [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-naming-conventions-around-the-world
5. GaBI Online - Generics and Biosimilars Initiative. FDA update on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Reports/FDA-update-on-naming-biologicals
6. GaBI Online - Generics and Biosimilars Initiative. WHO issues draft proposal for its biological qualifier [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Mar 12]. Available from: www.gabionline.net/Policies-Legislation/WHO-issues-draft-proposal-for-its-biological-qualifier
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