Biologicals in EU to be identified by brand names

Home/Policies & Legislation | Posted 22/02/2013 post-comment0 Post your comment

The European Commission has issued a directive, which requires biological products to be identified by brand name and not by international nonproprietary name (INN).


The European Commission’s Directive 2012/52/EU of 20 December 2012 lays down measures to facilitate the recognition of medical prescriptions issued in another Member State. The Directive was published in the Official Journal of the European Commission on 22 December 2012 and aims to enforce patients’ rights to cross-border healthcare within the European Union (EU).

The Directive requires that Member States of the EU recognize medical prescriptions issued in other Member States. In order to enable this recognition to take place the Directive states that 'in order to enable the correct identification of products’ the INN or common name should be used.

In contrast, the brand name of a medicinal product should only be used to ensure clear identification of biological medicinal products. This is stated in the Directive as necessary in order 'to ensure clear identification' of the biological product because of the 'special characteristics' of these products.

Global biosimilars manufacturers would of course prefer that biological products were prescribed by INN, as this would allow for possible substitution, and also enable biosimilars to grab a bigger market share. Prescribing by brand name will require much more intensive marketing by biosimilars manufacturers in order to increase brand awareness and encourage doctors to prescribe and patients to request biosimilars.

Advocates for unique naming for biosimilars have claimed that if a common INN were used patients would not know which drug they are getting. However, advocates for a common (INN) name for biosimilars, on the other hand, are concerned about possible overdosing or mis-dosing when different names are used, as a patient could inadvertently be prescribed two versions of the same biosimilar [1].

Editor’s comment
What is your opinion on the naming issue of biosimilars?  Should prescribing of biosimilars be done by brand name or by INN?

Please feel free to share your thoughts via email or in the comments section below.

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1.  GaBI Online - Generics and Biosimilars Initiative. Naming and interchangeability of biosimilars raised in new survey []. Mol, Belgium: Pro Pharma Communications International; [cited 2013 Feb 22]. Available from:

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Source: Europa

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