Pharmaceutical Technology Europe - August 2010 - (Page 3)

Interview with The European Generic Medicines Association The European Generic Medicines Association (EGA) is the official representative body of the European generic and biosimilar pharmaceutical industry, which is at the forefront of providing high-quality affordable medicines to Europeans and stimulating competitiveness and innovation in the pharmaceutical sector. Pharmaceutical Technology Europe spoke with Suzette Kox, Senior Director Scientific Affairs at the EGA to find out more about the environment for biosimilars. What is the EGA’s involvement in improving access to and the quality of biosimilars? In the context of biosimilar medicines, the EGA has been and continues to be a key stakeholder for the EU institutions, including the European Medicines Agency, as well as a key discussion partner for the World Health Organisation (WHO). The EGA, together with its members involved in developing biosimilar medicines, has contributed very actively to the key milestones achieved to date: • a robust legal and regulatory framework, guided by science • clarification regarding the biological medicinal same International Nonproducts. Consequently, proprietary Name (INN) as the term ‘biosimilar’ for the reference product should only be applied • WHO guidelines on the to biopharmaceuticals evaluation of similar that have been approved biotherapeutic products, in accordance with the based on the same scientific EU legal basis and data S u ze t t e K ox principles as in the EU requirements, or following EG A • clear identification of all a rigorous and extensive biopharmaceuticals by the approved comparability exercise at quality, name and the batch number for non-clinical and clinical level with an the purpose of suspected adverse ICH standard reference product, as reaction reports. required in the EU. It is also important to point out that Non-originator ‘copy’ the term ‘biosimilar’ is derived from biopharmaceuticals worldwide are EU legislation, which refers to similar often labelled as ‘biosimilars’ despite 1 CONTENTS 9 TAKING ON REGULATORS 3 EGA INTERVIEW 10 LAUNCHING A BIOSIMILAR 6 THE BIOSIMILARS MARKET 11 IMPACT ON INNOVATION 7 SWOT ANALYSIS 13 BIOSIMILARS NOT COMPELLING

Table of Contents for the Digital Edition of Pharmaceutical Technology Europe - August 2010

Pharmaceutical Technology Europe - August 2010
Table of Contents
The Changing Landscape for Biosimilars
Interview with The European Generic Medicines Association
The Biosimilars Market Today and Tomorrow
A SWOT Analysis of the Biosimilars Market
Latest EU Guidelines Dissected
Taking On the Regulators: Is It Worth It?
Launching and Commercialising Biosimilars
Perception, Cost and the Impact on Biotech Innovation
Clinical and Cost Considerations of Developing a Biosimilar
True Biosimilars Do Not Offer a Compelling Business Case
What is Hindering the Uptake of Biosimilars

Pharmaceutical Technology Europe - August 2010