BioWorld International Correspondent

BRUSSELS, Belgium - Lithuania, one of the European Union's newest member countries, is under attack for failing to comply with EU rules on authorization of generic biotech medicines - "biosimilars," in EU jargon.

EU officials have decided that there is prima facie evidence that a biosimilar product placed on the market a year before Lithuania joined the EU in 2004 does not meet EU requirements.

The product in question is Grasalva a recombinant human granulocyte colony stimulating factor from Sicor Biotech UAB, a subsidiary of the generic company Teva. It obtained a Lithuanian market authorization in 2003. In the first case of its kind, the EU's Court of Justice has been asked to give a ruling.

EuropaBio - the EU association for bioindustries - immediately welcomed the action against Lithuania. It said the 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." According to EuropaBio, Lithuania did not abide by the European legal framework, which would have required removal of the product 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 European medicines agency. In order to best ensure patient safety, it is important that health care systems in all EU member states meet the same high safety standards," commented Andrea Rappagliosi, EuropaBio's chair of the Healthcare Council.