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.”