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European Court of Justice to rule on Lithuania's failure to abide by European law on biosimilars

11 Dec 2007 - EuropaBio - the EU association for bioindustries - welcomes the European Commission's action against Lithuania in the European Court of Justice on the grounds that a biosimilar product placed on the Lithuanian market does not meet the requirements of European law. The biosimilar product in question fails to meet the approval standards set by the EU as it has not completed clinical and other tests to verify its safety and efficiency. In this instance, Lithuania did not abide by the European Legal Framework, which would have required Lithuania to remove the biosimilar from the market.
 
"It is absolutely critical, and indeed unquestionable, that all medicines available to Europe's citizens meet the safety, efficacy and quality standards set by the EMEA. In order to best ensure patient safety, it is important that healthcare systems in all European Union Member States meet the same high safety standards" commented Andrea Rappagliosi, EuropaBio's Chair of the Healthcare Council.
 
"The biotechnology industry is committed to ensuring that all products on the European market are safe and efficacious for patients. We therefore strongly support the European Commission's action, as it is a tangible sign of a transparent and patient-oriented implementation of the EU biosimilar legal system." Dr Rappagliosi said.