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?
11th EGA ANNUAL LEGAL AFFAIRS FORUM PROMOTES HEALTHCARE SUSTAINABILITY AND JOB CREATION IN EUROPE
Brussels, 26 March 2015 - The European Generic and Biosimilar medicines Association holds its 11th Legal Affairs Forum today and tomorrow in Brussels. This event brings together company executives, regulators, EU authorities and other industry leaders to discuss key legal issues impacting the generic and biosimilar medicines industries.
A SIGNIFICANT MILESTONE FOR PATIENT ACCESS: FIRST US FDA BIOSIMILAR MEDICINE APPROVAL
Brussels, 9 March 2015 - The European Generic and Biosimilar medicines Association welcomes the US Food and Drug Administration (FDA) approval of the first biosimilar medicine on March 6th. Noteworthy is that biosimilar filgrastim is approved for the same indications as its reference medicine. This approval is another significant milestone for patients after the European-wide launch of the first biosimilar monoclonal antibody infliximab. Since 2006, EU approved biosimilar medicines have already generated more than 400 million patient days of clinical experience.
EGA INTRODUCES ITS CODE OF CONDUCT FOR THE EUROPEAN GENERIC AND BIOSIMILAR MEDICINES INDUSTRIES
Brussels, 5 March 2015 - Following the adoption of the European Commission Guiding Principles Promoting Good Governance in the Pharmaceutical Sector initiated by the Former Vice-President of the Commission, Antonio Tajani, the EGA (European Generic and Biosimilar medicines Association) is pleased to strengthen its commitment on ethics and transparency by introducing its Code of Conduct today.
NEW LANDMARK IN FIGHT AGAINST COUNTERFEIT MEDICINES WITH ESTABLISHMENT OF THE EUROPEAN MEDICINES VERIFICATION SYSTEM
Brussels, 19 February - Major European healthcare stakeholders have taken a major step to secure the legitimate pharmaceutical supply chain against the risk of falsified medicines, as required by the EU Falsified Medicines Directive.
26 - 27 March 2015
23 - 24 April 2015
30 April 2015
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