Position papers

Guide on Biosimilars in Europe

A close look at biosimilar standards, identification, traceability and economics.

As a distinct class of new medicines, biological medicines have opened up new frontiers in the treatment of serious diseases helping patients live longer, and reducing the related social and economic burden of these diseases.

Scientific research and development has also been positively impacted as the share of biological medicines among new treatment options continues to grow. Three decades on after the first biological medicines were launched, exclusivity rights on the early biological medicines have begun to expire, and thus present an opportunity for pharmaceutical companies to consider developing biosimilar medicines of these products. Against this background, and given biosimilars’ unique characteristics in comparison to chemically-synthesised small-molecule medicines, European regulatory authorities and national governments (in collaboration with diverse stakeholders) have established a specific regulatory framework for biosimilars which continues to evolve.

EuropaBio brings together small and large biotechnology companies, of which several are developing both novel biological medicines as well as biosimilar medicines. Biosimilars have an important role to play in fostering competition in the market place, and thereby contributing to the sustainability of healthcare budgets. We believe that Europe must continue to be a thoughtful and responsible leader in this regard to ensure that its regulatory frame-work and practices are of the highest scientific standards and ensure European patients’ safety.

With this brochure, EuropaBio seeks to continue its contribution to the policy debate on biosimilars by generating a better understanding and appreciation of the key issues for European regulators and national policy makers, e.g. the imperative for identification and traceability of biological medicines, with implications for naming and labelling conventions, as well as healthcare systems’ sustainability.

Read the guide on your screen or download a PDF copy below.