To contribute to an informed debate, EuropaBio is launching a new brochure acknowledging the complexity of biotechnology-derived medicines[1] and the emergence in Europe of a new category of biotech medicines: biosimilars.

Following the definition of the European Medicines Agency (EMA) and the establishment of a regulatory approval pathway, EuropaBio believes that due to the unique nature of biological medicines and biosimilars, the latter should not be treated in the same way as a generic of a chemical medicine. Since introducing the concept of biosimilars in its legislation in 2004, the European Union has been at the forefront of the development of a strong science-based regulatory pathway for biosimilars, providing patients with the assurance that these products are safe and successful. In the context of global economic and financial constraints, biosimilars may have an important role to play in fostering competition in the market place and thereby contributing to the sustainability of healthcare budgets and securing the necessary funds to pay for further innovation.

A biosimilar is a medicine that is similar – but not identical – to a biological medicine that has already been authorised. Due to the complex way in which biotech-derived medicines are manufactured, biological medicines generally show a higher variability than small molecules which could potentially induce unwanted and even harmful reactions. It is therefore important that any change in treatment is carefully managed by a treating physician in close dialogue with patients, particularly in the case of chronic diseases and long-term treatments.

Recently adopted EU legislation on pharmacovigilance, which is currently being implemented in Member States, should play a vital role in maintaining safety standards for all biotech medicines, including biosimilars. This can be achieved by ensuring a correct and precise identification of the product that is prescribed and dispensed as well as ensuring the assessment of the immunogenicity as a key component in the Risk Management Plan of any biological medicine. With biotechnology-derived medicines, it is important that in case of adverse events, products can be identified by the product batch. EuropaBio advocates the use of the products’ brand name when prescribing medication.  The implementation of the new pharmacovigilance legislation offers a timely opportunity to put these best practices in place across the European Union.

EuropaBio Healthcare Council Chair, Thomas Bols stated: “By producing this new report on Biosimilars, EuropaBio wants to actively contribute to the debate on biosimilars by making factual information available on this class of medicines within the biotech medicines field.  It is essential that evidence-based decision making occurs in Europe on this issue whether that be in the EU institutions or in the clinic”.

As the discussions continue in Europe to further develop the regulatory pathway for biosimilars, new initiatives to foster multi-stakeholder dialogue, such as the Process on Corporate Responsibility in the Field of Pharmaceuticals initiated by Vice President Tajani, provide the opportunity to extend the debate to other relevant aspects of biosimilars including market access.  This brochure is EuropaBio’s contribution to these forums.

[1] Also referred to as biological medicines

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Please find a link to the report here

About EuropaBio: EuropaBio's mission is to promote an innovative and dynamic biotechnology based industry in Europe. EuropaBio, (the European Association for Bioindustries), has 62 corporate and 7 associate members operating worldwide, 2 Bioregions and 19 national biotechnology associations representing some 1800 small and medium sized enterprises.

About Healthcare Biotech: Healthcare biotechnology refers to a medicinal or diagnostic product or a vaccine that consists of, or has been produced by the use of, living organisms.  Often recombinant DNA (a form of DNA that does not exist naturally and which combines DNA sequences that would not normally occur together in order to establish new functions) forms the basis for such biotechnologically manufactured products.  EuropaBio’s healthcare biotech companies are working in areas as diverse as: Orphan Medicinal Products (OMPs), Health Technology Assessment (HTAs), personalised medicine and rare diseases.

For further information, or quotes please contact:

Rosalind Travers

Communications and Associations Liaison Officer

Tel: +32 2 739 1173

Mobile: +32 478 680 301

Email: r.travers@europabio.org

Or

Ludovic Lacaine

Director, Healthcare Biotechnology

Tel: +32 739 1183

Email: l.lacaine@europabio.org

www.europabio.org