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Call for action on labelling of biosimilars Posted 26/09/2014

European trade association, the European Association for Bioindustry (EuropaBio) has called on the European Medicines Agency (EMA) to define specific guidance on the labelling of biosimilars.

EuropaBio published a statement on 15 September 2014 giving the perspective of the healthcare biotechnology industry on the labelling of biosimilars. In the statement, Members of the EuropaBio Healthcare Council called for specific guidance on the labelling of biosimilars, in order to take into account the specificities of these products and facilitate their understanding and acceptance by patients and physicians.

The association is calling for ‘biosimilars need to be labelled in a clear and transparent way’, which they believe will allow physicians ‘to make informed decisions when selecting the most appropriate medicinal product for their patients’.

EuropaBio points out that currently the format and content of labelling is governed by EMA’s Quality Review of Documents guidance (EMA/627621/2011), which does not distinguish between biosimilars, generics and hybrid products.

In its proposal, EuropaBio suggests the labelling of biosimilars should combine information on both the biosimilar and the reference product, so that it is clear whether the data presented was generated for the reference or the biosimilar product, and which indications have been approved for each product.

The Association of the British Pharmaceutical Industry (ABPI), which represents innovative research-based biopharmaceutical companies in the UK, has also given a similar recommendation in its position paper on biosimilars [1]. The ABPI recommends that the summary of product characteristics (SmPC) for a biosimilar should clearly indicate the source of information contained within it, such as relevant data from its clinical development programme and clinical data derived from the reference biological.

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1.   GaBI Online - Generics and Biosimilars Initiative. ABPI issues updated position paper on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Sep 26]. Available from: www.gabionline.net/Biosimilars/General/ABPI-issues-updated-position-paper-on-biosimilars

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Source: EuropaBio

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