The differential naming of originator and biosimilar products supports accurate pharmacovigilance and promotes biosimilar uptake, finds a literature review recently published in GaBI Journal [1].
There is a long-standing debate regarding the naming of biological drugs. The World Health Organization introduced the concept of a biological qualifier (BQ) for naming biologicals in 2014, a random code of four letters to be used in conjunction with the International Nonproprietary Name (INN) [2].
In the EU, as well as the INN, the brand name, batch number and lot number of a biological must be recorded, whether it is an originator product or a biosimilar, and biosimilars can have the same non-proprietary name as their reference biological. Biosimilars can still be tracked using their brand name and other identifiers, e.g. batch number.
The US Food and Drug Administration’s latest guidance on the naming of biological drugs however requires the addition of a distinct four-letter suffix to the non-proprietary name of a biological [3]. The potential benefits of this approach include more accurate pharmacovigilance and product-specific tracking.
However, some (including the Federal Trade Commission) argue that this naming approach will generate confusion and be harmful to biosimilars manufacturers, as having distinguishable non-proprietary names could lead doctors to believe there is a difference in the originator and biosimilar, potentially discouraging the prescribing of biosimilars.
The Biosimilars Forum also raised concerns that this new approach will promote the idea that ‘strict pharmacovigilance is only essential for biosimilars’ and ‘fuel misinformed ideas about biosimilars’ [3].
A recent literature review [1] investigated the issue of biological naming protocols. The study addressed the impact of introducing a distinct suffix to biological product non-proprietary names on stakeholders including regulatory agencies, physicians, payers, patients, government agencies and advocacy groups. The aim was to explore the connection between the use of differential nomenclature and safety reporting, effectiveness and prescriber confidence in biosimilars.
The review suggests that use of a distinct four-letter suffix could reduce ambiguity during adverse event reporting, promote effective pharmacovigilance and help to alleviate physician concerns regarding extrapolation (using biosimilars in indications where approval was extrapolated from other clinical data).
The authors suggest that a differential naming policy supports product traceability, manufacturer accountability, and more accurate measurements of efficacy and safety outcomes. They conclude that use of a distinct four-letter suffix for biologicals will improve physician and patient approval of biosimilars and thus enable a competitive marketplace for biosimilars.
Conflict of interest
The authors of the research paper [1] reported conflict of interest, including being employee of pharmaceutical company. For full details of the authors’ conflict of interest, see research paper [1].
Editor’s comment
Readers interested to learn more about the naming of biological drugs are invited to visit www.gabi-journal.net to view the following manuscripts published in GaBI Journal:
The challenges of nomenclature – INN, biosimilars and biological qualifiers
Naming and labelling of biologicals – a survey of US physicians’ perspectives
US FDA proposals for naming of biologicals and labelling of biosimilars
Readers interested in contributing a research or perspective paper to GaBI Journal – an independent, peer reviewed academic journal – please send us your submission here.
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References
1. Sarshad M, Campbell R, Pitts P et al. The need for distinct nomenclature for originator and biosimilar products. Generics and Biosimilars Initiative Journal (GaBI Journal). 2018;7(4):152-7. doi:10.5639/gabij.2018.0704.031
2. GaBI Online - Generics and Biosimilars Initiative. Stakeholders question FDA’s guidance on naming biologicals [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Guidelines/Stakeholders-question-FDA-s-guidance-on-naming-biologicals
3. GaBI Online - Generics and Biosimilars Initiative. Biosimilar naming conventions around the world [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2019 Aug 9]. Available from: www.gabionline.net/Biosimilars/Research/Biosimilar-naming-conventions-around-the-world
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