Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), has changed its plans for naming biosimilars, ‘following recent international developments in the area of biosimilar naming’.
In a press statement on 20 January 2015, TGA announced that it ‘will not be continuing with the previously proposed naming convention for biosimilars while a review of the policy is undertaken’.
The agency had previously proposed [1] that all biosimilars in Australia have distinguishable names and that the name of a biosimilar be made up of:
- the reference product Australian Biological Name (ABN), thus identifying the reference product with which the biosimilar has demonstrable comparability, and
- a biosimilar identifier, consisting of the prefix sim(a)- and a three-letter code issued by the World Health Organization (WHO) International Nonproprietary Name (INN) Committee, according to its draft policy.
However, in July 2014 WHO INN published a draft policy ‘Biological Qualifier - An INN Proposal’ proposing a possible four-letter alphabetic code for all biologicals [2]. This proposal has superseded the previous INN position on which the TGA policy was based. This means the TGA biosimilar naming convention cannot be implemented and TGA is undertaking a review of the policy.
In the interim biosimilars will use the ABN without a specific biosimilar identifier suffix, for example, a biosimilar to the reference product Neupogen filgrastim would be named ‘TRADENAME’ filgrastim.
Advocates for unique naming for biosimilars have claimed that if a common non-proprietary name were used, patients would not know which drug they are getting [3]. While advocates for the same INN have argued that unique names or modified INNs for biosimilars would impede their ability to compete fairly in the marketplace, create confusion and limit patient access to these critical medicines. The Generic Pharmaceutical Association has proposed using manufacturer names to distinguish biosimilars as a compromise [4].
Biosimilars using the same INN as their reference products have been on the market in Europe since 2006. Existing naming systems, requiring biologicals to be identified through the recording of brand name and batch number, have worked very well. In fact, biosimilars have been used safely since 2006 and pharmacovigilance data shows that current tracking and adverse event reporting systems work well [5].
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References
1. GaBI Online - Generics and Biosimilars Initiative. Naming requirements in Australian biosimilars guidance [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Guidelines/Naming-requirements-in-Australian-biosimilars-guidance
2. 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 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances
4. GaBI Online - Generics and Biosimilars Initiative. GPhA proposes using manufacturer names to distinguish biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Biosimilars/General/GPhA-proposes-using-manufacturer-names-to-distinguish-biosimilars
5. GaBI Online - Generics and Biosimilars Initiative. Biologicals in EU to be identified by brand names [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Jan 23]. Available from: www.gabionline.net/Policies-Legislation/Biologicals-in-EU-to-be-identified-by-brand-names
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