On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals and biosimilars to have the same International Nonproprietary Name (INN).
Biosimilars using the same INN as their reference products have been on the market in Europe since 2006 with a proven safety record, and there have been no issues with traceability or pharmacovigilance [1].
The organizations, which include pharmacies, labour unions, state retirement systems and payors, state in the letter that they ‘believe that the current mechanisms in place [e.g. national drug code (NDC), lot number, brand name, manufacturer, etc.] are sufficient’. They argue that ‘because adverse events and product recalls for small molecule and biologic[al] drugs already are successfully identified using the NDC code and lot number, there is no compelling evidence that biosimilars should be handled differently.’
While Mr Ralph G Neas, President and CEO of the Generic Pharmaceutical Association (GPhA), said that the ‘INN approach to biosimilar naming has proven safe and effective in Europe’. He also added that ‘it has worked in the United States for chemical drugs and currently approved biologic[al]s, therefore, it should be the standard for US biosimilars.’
The letter follows concerns recently raised by the National Council for Prescription Drug Programs (NCPDP), which cited serious operational problems with the implementation of a system other than the currently accepted INN construct.
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 [2]. The World Health Organization (WHO) is also considering the use of a biological qualifier (possibly a four-letter code) to distinguish biosimilars [3]. While the GPhA has proposed using manufacturer names to distinguish biosimilars as a compromise [4]. One thing is for sure the debate is not over yet.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Fight continues over biosimilar naming standards [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/General/Fight-continues-over-biosimilar-naming-standards
2. GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/General/FDA-s-public-hearing-on-biosimilars-draft-guidances
3. 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 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/General/WHO-investigates-use-of-a-biological-qualifier-for-biosimilars
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 2014 Jul 4]. Available from: www.gabionline.net/Biosimilars/General/GPhA-proposes-using-manufacturer-names-to-distinguish-biosimilars
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