Press release

EuropaBio calls for EMA action on labeling of biosimilars

EuropaBio has published a statement giving the perspective of the health care biotechnology industry on the labeling of biosimilars.

Members of the EuropaBio Healthcare Council call on the European Medicines Agency to define 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. In particular, EuropaBio supports a transparent label that combines information on both the biosimilar and the reference product.

“We believe biosimilars need to be labeled in a clear and transparent way in order to facilitate the understanding and acceptance of these products on the part of physicians and patients” explained Nathalie Moll, EuropaBio secretary general, adding: “Transparent labeling allows physicians to make informed decisions when selecting the most appropriate medicinal product for their patients, and we welcome any initiatives by European regulators to provide more specific guidance on this aspect.”

Should combine information on both the biosimilar and the reference product

Format and content of labeling is governed by the EMA’s Quality Review of Documents guidance (EMA/627621/2011) which does not distinguish between biosimilars, generics and hybrid products. Because of the nature of biosimilars, which are recognized as a distinct category of medicinal products and have a different regulatory approval pathway than both originator products and generics in the European Union, EuropaBio suggests the labeling 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 full article is available here.