Biosimilars

A biosimilar is a biologic medicine containing a version of the active substance of an already authorised original biologic medicine (reference medicinal product), and which has shown similarity to the reference medicinal product in terms of quality, biological activity, safety and efficacy based on a comprehensive comparability exercise* .

Biosimilars can be developed during the period in which the originator product is protected by patent exclusivity, but they can only be marketed after the patent protecting the originator product has expired**

EuropaBio’s members develop patented (innovator) biologic medicines, biosimilars, or both. Based on this broad representation, EuropaBio works to help European regulators and national policy makers understand the key issues surrounding biosimilars, such as the imperative for identification and traceability of all biologics, with implications for naming and labelling biosimilars, the appropriate terms of use for biosimilars as well as their role in fostering sustainability of healthcare systems.

 

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