Press release

EuropaBio launches guide and position paper on biosimilars

EuropaBio launches guide and position paper on biosimilars

Brussels, 6th October 2014 - Today, EuropaBio published a new Guide and a new Position Paper on Biosimilars in Europe. With these two documents, EuropaBio continues its contribution to the policy debate on key issues regarding biosimilars among European and national regulators, policy makers, physicians, other healthcare providers and patients.

Entitled “When Science Meets Policy”, EuropaBio’s new ‘Guide on Biosimilars in Europe’ provides basic facts about biological medicines, including biosimilars, and explains why Europe needs to continue to maintain high standards for biosimilars. Both the Guide and the Position Paper stress the need for: distinguishable non-proprietary names for all biological medicines to enhance traceability; transparent information in biosimilar product labels, to facilitate physician and patient understanding as well as respect for physicians’ prescribing authority; and appropriate terms of use in particular for well-treated patients.

The papers ultimately call on EU and national decision-makers to further develop a policy framework that fully takes into account the specificities of biosimilars, especially when compared with chemically-synthesized small molecule generic medicines.

“The EU framework on biosimilars has served as a reference for many other regulators around the globe.” explained Nathalie Moll, EuropaBio Secretary General. “We believe that Europe must continue to be a thoughtful and responsible leader in this regard to ensure that its regulatory framework and practices are of the highest scientific standards and guarantee patients’ safety”.

“As the development of new biosimilar medicines continues to increase, the understanding of these medicines will evolve. Therefore it will be critical for Europe to continue to adopt new insights and to adjust existing guidelines and practices as appropriate” commented Emmanuel Chantelot, Chair of EuropaBio’s Healthcare Council.

Biological medicines have opened new frontiers in the treatment of serious diseases helping patients live longer, and reducing the related social and economic burden of these diseases. Biosimilar medicines are follow-on versions of original biological medicines (known as the “reference product”) which can be introduced on the market once exclusivity rights of the original product have expired.

Biosimilars are sometimes incorrectly and inappropriately called "generic" versions of original biological medicines. Unlike generics, which are identical copies of chemically-synthesised medicines, biosimilars are in fact not identical to the original biological medicines, but only highly similar.  Being produced by living systems, biological medicines are highly sensitive to minor changes in their physiological environment, thus their manufacturing processes need to be carefully controlled in order to obtain consistent results and to guarantee the safety and efficacy of the medicine.

ENDS

- EuropaBio Guide on Biosimilars in Europe

- EuropaBio Position Paper on Biosimilars in Europe -

 

About EuropaBio:

EuropaBio is the European Association of BioIndustries. Our members are involved in research, development, testing, manufacturing and commercialisation of biotech products and processes in human and animal healthcare, diagnostics, bioinformatics, chemicals, crop protection, agriculture, food and environmental products and services. EuropaBio also counts a number of National Biotech Associations in its membership who in turn represent more than 1800 biotech SMEs.