Biosimilar medicines: an opportunity for healthcare
Since 2006, biosimilar medicines have generated more than 400 Million patient days of clinical experience. Healthcare professionals and patients can be confident that authorised biosimilar medicines have been demonstrated to be of high quality and as safe and efficacious as their reference product. So what are biosimilar medicines?
EU Semester structural reforms for healthcare: access must be a priority
Brussels, 13 May 2015 - Today, the European Commission will publish its recommendations for structural reforms in the form of Country Specific Recommendations (CSR). For healthcare, which is a rapidly growing share of public spending, the EGA highlights the need for a shift away from unsustainable short-term cost-containment measures which could restrict access for patients.
The European Parliament calls on the Commission to foster the export of EU Generic and Biosimilar medicines
Brussels, 7 May 2015 - The Committee on International Trade (INTA) of the European Parliament voted today on the Mosca Report “Strategy for the protection and enforcement of Intellectual Property Rights in third countries” calling on the Commission to stimulate early export of generic and biosimilar medicines to countries where no patent or supplementary protection certificates (SPC) exist.
1.4 Billion Euros per year in potential savings for patients from the use of generic medicines in Italy
Rome, 6 May 2015 - A Nomisma report on ‘The system of generic medicines in Italy – Scenarios for sustainable growth’ was presented in the Senate of the Italian Republic this week in the presence of Enrique Häusermann, President of Assogenerici, AIFA (the Italian medicines agency), the Ministries of Health and Economic Development, as well as members of different committees of the two Houses of the Italian Parliament.
Joining forces to promote Universal Access to Health
Brussels, 5 May 2015 - The European Generic and Biosimilar medicines Association (EGA) organised a roundtable on ‘Universal Access to Health, a year after the EU elections’ today in Brussels together with the European Patients Forum, International Association of Mutual Benefit Societies and Doctors of the World. Over 70 participants debated ways to ensure universal access to healthcare across the EU.
09 - 11 June 2015
Leading on health equality and sustainable access to medicines for European patients More details available here
EGA Vision 2015, the Way forward for more Efficient Regulatory Environment for Generic and Biosimilar Medicines
GfK Final Report- Factors Supporting a Sustainable European Biosimilar Medicines Market
GfK Final Report - Factors Supporting a Sustainable European Biosimilar Medicines Market GfK Final Report- Factors Supporting a Sustainable European Biosimilar Medicines Market
Biosimilars: The science of extrapolation
Martina Weise, Pekka Kurki, Elena Wolff-Holz, Marie-Christine Bielsky, and Christian K. Schneider, Biosimilars: The science of extrapolation, Blood, 20 November 2014, Volume 124, NUMBER 22 Biosimilars_the_science_of_extrapolation.pdf
(free download for non-industry stakeholders only)
EGA Biosimilars Handbook
EGA Biosimilars Handbook
English version EGA_BIOSIMILARS_handbook_en.pdf
German version EGA_Biosimilars_ProGen-Biosimilars-A5-RZ-web_ende.pdf
Italian version EGA_BIOSIMILARS_IT.pdf
Spanish version EGA_BIOSIMILARS_INT_Spain.pdf