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?
Statement on GVK BIO EU referral
27 July 2015 - The European Generic and Biosimilar medicines Association (EGA) and its members have an absolute commitment to quality for medicines in Europe and to the well-being and safety of patients. Further to the European Commission’s (EC) decision on the GVK CRO investigation which is entirely in line with the previously published European Medicines Agency’s (EMA) recommendation, EGA members have been active in conjunction with the competent authorities since the EMA has issued their advice and will continue to do so. The EMA indicates that there is no evidence of harm or lack of effectiveness linked to the conduct of studies by GVK Biosciences and that medicines considered critically important for patients will remain available.
Successful Link with Germany’s securPharm Makes EMVS a Reality
Brussels, 23 July 2015 - The European Medicines Verification System (EMVS) has passed another significant milestone in its development process by successfully implementing its first Hub connection with a Member State. This achievement is a major step along the road to securing the legitimate pharmaceutical supply chain against the risk of falsified medicines.
EMVO Efforts against Falsified Medicines Invigorated by Appointment of New President
Brussels, 20 July 2015 - Four months after its official establishment in February this year, the European Medicines Verification Organisation (EMVO) has appointed a new President. Designated to the post on June 19, Sonia Ruiz Moran is replacing John Chave, former Secretary General of Pharmaceutical Group of the European Union (PGEU).
EGA welcomes new EU logo to help patients avoid online sellers of fake medicines
Brussels, July 7 2015 - The European Generic and Biosimilar medicines Association (EGA) welcomes the introduction of the new EU logo to help patients avoid online sellers of fake medicines. From 1 July, all online pharmacies or retailers of medicines legally operating in the EU should display a new logo introduced by the Falsified Medicines Directive (2011/62/EU) to protect patients.
16 - 19 September 2015
27 January 2016
28 - 29 January 2016
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