Competitiveness of the EU biosimilar medicines industry
14/2/2011 - EGA calls for an EU industrial policy to enhance the competitiveness of the EU biosimilar medicines industry
“There is a need for an EU industrial policy for the biosimilar medicines industry. The EGA will therefore continue to be at the forefront of the biosimilars debate working with EU and global policy makers” said Didier Barret, EGA President, in his opening address to the 9th EGA International Symposium on Biosimilar Medicines today in London. The EGA President welcomed the EU biosimilars’ framework which is operational and delivering, he also reminded the audience that biosimilar medicines have been safely in use for 5 years.
Greg Perry, EGA Director General, in his talk developed the additional EU regulatory and industrial policy measures which are needed to capitalise on the EU advanced framework. “New and smart approaches are needed in order to facilitate further development and the sustainability of this industry sector”, he said. “The regulatory framework should be adapted to allow and accept global development programmes for biosimilars in order to ensure the availability and affordability of this important category of medicines”.
Mr Perry also made a plea for the EU to increase the promotion of its high standards beyond its borders for the sake of patients worldwide. “There should be no second-rate standards”, Mr Perry insisted. He further proposed measures to encourage development and manufacturing in Europe which is in line with the Commission ‘Europe 2020’ agenda. Mr Perry also welcomed and supported the DG Enterprise project group on market access and uptake of biosimilars. The objective of this project will be to define what the necessary conditions within the pharmaceutical environment are to ensure informed and adequate access and uptake of biosimilar medicinal products. “For the sake of Europe’s patients”, Mr Perry concluded, “we need incentives for the demand-side, a consistent rational approach towards interchangeability, acceptance of different cost-price structures than for generic medicines, and an increase of awareness and information aiming at reinforcing the confidence of patients and healthcare professionals in these high quality biopharmaceuticals.”
EGA LAUNCHES SECOND EDITION OF BIOSIMILARS HANDBOOK
At the occasion of its 9th EGA International Symposium on Biosimilar Medicines, the EGA launched the second edition of its Biosimilars Handbook. This handbook aims to provide updated information on the current progress of biosimilar medicines in the European Union. The situation has developed and changed since the first edition in 2007 and the clinical and health economic benefits offered by biosimilar medicines to patients, clinicians, pharmacists and healthcare providers are considerably clearer. Suzette Kox, EGA Senior Director Scientific Affairs, presented selected key messages from the new edition. “The science of the thorough and step-wise comparability exercise, which is the pillar of a biosimilar product development and market approval, is presented in detail”, Ms Kox explained. “We trust that this second edition continues educating and informing about biosimilar medicines”, she concluded.
The Biosimilars Handbook can be purchased here.
It is available free of charge for government organisations, NGOs and academia by sending a request to Esta dirección de correo electrónico está protegida contra spambots. Usted necesita tener Javascript activado para poder verla.
