European Court Of Justice To Rule On Lithuania's Failure To Abide By European Law On Biosimilars

Main Category: Pharma Industry / Biotech Industry
Article Date: 10 Dec 2007 - 3:00 PDT

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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 (1) placed on the Lithuanian market does not meet the requirements of European law (2). 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.

References

(1) The product in question is called Grasalva is a recombinant human, granulocyte colony stimulating factor (G-CSF) that helps to increase white blood cells, in cancer patients. Sicor Biotech UAB, a subsidiary of the generic company Teva, received a Lithuanian market authorisation in 2003.

(2) According the Secretariat Generals' website - Commission decision of 17 October 2007

Biosimilars

Biosimilars are similar but not identical products to the original innovative biotechnology product. In 2006, the EU set forth a regulatory and approvals pathway to bring biosimilars to market. Because biotech medicines are structurally very complex, small distinctions in the manufacturing process can cause a major difference in the products' side effects. Therefore, the European approvals pathway has strict requirements that must be adhered to for any biosimilar product in a European country.

This approvals process is part of the European legal framework, the acquis communitaire. All new countries joining the European Union must abide by this legal framework, and it is the European Commission's responsibility to ensure that all EU Member States respect the Union legal framework.
About EuropaBio

EuropaBio is the European Association for Bioindustries, solely and uniquely bringing together bioscience companies from all fields of research and development, testing, manufacturing and distribution of biotechnology products. It has 84 corporate members operating worldwide, 8 associate members, 6 BioRegions and 25 national biotechnology associations representing some 1800 small and medium sized enterprises involved in research.

http://www.europabio.org