Fight continues over biosimilar naming standards

Biosimilares/General | Posted 27/09/2013 post-comment0 Post your comment

Biosimilar products marketed in the US should share the same common non-proprietary name as the reference brand-name biological medicine, according to the Generic Pharmaceutical Association (GPhA).

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GPhA, which represents the generics industry in the US, has filed a Citizen Petition with FDA recommending that ‘all biosimilars approved by the agency share the same international nonproprietary name (INN) as the biologic[al] products to which they refer’. GPhA reasons that because by definition biosimilars are ‘highly similar to the reference biologicals’, they therefore ‘have no clinically meaningful differences that require a unique name’.

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 [1]. However, GPhA in its petition argues that ‘unique names will not enhance safety’. The industry group adds that 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. They also point out that in the US, pharmaceutical and biological products are successfully traced using national drug codes (NDCs), batch and lot numbers.

Biotechnology giant Amgen, however, disagrees stating that ‘all biologic[al] medicines need a distinguishable component in their non-proprietary (proper) name’. Amgen states that this will enable patients, caregivers, healthcare professionals, regulators and industry to ‘more readily and accurately identify, investigate and report adverse events’. The company is therefore seeking ‘distinguishable non-proprietary names (common root and a distinguishable component)’ for their biosimilars.

GPhA on the contrary argues that ‘to upset the naming system in place risks engendering confusion and would have a major negative impact throughout the global pharmaceutical supply chain, potentially jeopardizing patient access across the globe’. They also point out that the INN system, administered by the World Health Organization (WHO), ‘has been in place for 50 years’, keeping patients safe and ‘should not be changed for one subset class of products’.

The issue is not just related to the US. The International Generic Pharmaceutical Alliance (IGPA), which promotes generics worldwide, has also written to Australia’s drug regulatory agency, the Therapeutic Goods Administration (TGA), concerning the issue of naming of biosimilars in the country.

IGPA stated in its letter that it has ‘serious concerns’ about the naming recommendations for biosimilars proposed by TGA in its guidance document ‘Evaluation of Biosimilars’. IGPA states that ‘naming should be based on consistent scientific principals as it has been for decades. Further, the lack of global consistency for naming of biosimilars will result in a loss of scientific basis for naming, confusion and uncertainty for practitioners and patients and inappropriately delayed access to affordable biologicals.’

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1.  GaBI Online - Generics and Biosimilars Initiative. FDA’s public hearing on biosimilars draft guidances []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Sep 27]. Available from:

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Source: Amgen, GPhA, IGPA

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