Biosimilars: Commission sues Lithuania
Vilnius/Brussels – For the first time, the European Commission has taken a member state of the European Union to the European Court of Justice because it refuses to take a biosimilar from the market. Lithuania has refused to withdraw the granulocyte colony-stimulating factor (G-CSF) biosimilar Grasalva made by Sicor Biotech UAB, a subsidiary of Teva, from the market because it says that at the time of its registration in 2003, the treatment for chemotherapy-induced neutropenia was fully in line with applicable EU and national legislation.
Both the Commission and EuropaBio, the EU bioindustries association that advised the Commission of the situation, have taken a different view. They say the product must be approved according to the EMEA guideline on biosimilar G-CSF products – with Amgen’s Neupogen (filgrastim) as a reference product – as of June 2005. The Lithuanian authorities say that there is no reason to re-register Grasalva, as it was registered before the country’s EU accession. In December, the Court put the topic on fast-track. “This is a very important case because it is about accession countries ensuring that all of the products on their market meet EU regulations,” said Thomas Bols, director of government affairs for Europe at Amgen and a chair of EuropaBio’s biosimilars task force to Scrip.