Baltic Countries

Biosimilars: Commission sues Lithuania

19.02.2008

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.

Baltic Countries

17.08.2011

Under the motto “10 Years ScanBalt Bioregion – Towards a Balanced Regional Development and Smart Specialisation in the Baltic Sea Region”, the ScanBalt Bio­Region is holding the 10th ScanBalt Forum from September 21st-23rd....

Baltic Countries

11.06.2011

Kaunas – US-based Valeant Pharmaceuticals International Inc. said in mid-May that it is purchasing an 87.2% share in Lithuanian generic drug maker Sanitas AB for EUR314m in cash, and will make a mandatory tender offer to acquire...

Baltic Countries

25.05.2011

Kaunas – US company Valeant Pharmaceuticals International, Inc. wants to purchase Lithuanian generic drug maker Sanitas AB for EUR314 million in cash. Shareholders of Sanitas have already agreed to sell Valeant 87.2% of Sanitas’...

Baltic Countries

03.11.2010

Bucharest – Plans by Romanian Environment Minister Lazlo Borbely to implement a five-year ban on GMO acreage beginning next spring have been fiercely attacked by the country’s Agriculture Minister Valeriu Tabara. Borbely has...

Baltic Countries

16.09.2010

Kopavogur – Iceland’s ORF Genetics Ltd. and the Indian company DM Corp. Pvt. Ltd. are planning to collaborate on the development, production and marketing of protein drugs. The two CEOs Björn Örvar (ORF) and Dilip Mohite (DM...

Baltic Countries

12.09.2010

Vilnius/Waltham – Lab giant Thermo Fisher Scientific has completed its EUR212m cash takeover of Lithuania‘s largest lab tools provider Fermentas Inter­na­tional. Integration of the firm into Thermo Fisher’s Analytical...

Baltic Countries

08.09.2010

Riga – According to an announcement following a meeting of senior staff in mid-August, JCS Grindeks will collaborate in product development with the Latvian Institute of Organic Synthesis (IOS). The collaboration will involve the...

Baltic Countries

09.07.2010

Riga – Latvian pharma manufacturing firm Grindeks has announced it will significantly increase revenues to EUR13.5m this year. Issued in mid-June, the prognosis was based on good sales in eastern European markets in the first...

Baltic Countries

02.07.2010

Vilnius/Waltham – The life sciences tools market is slowly being whittled down to a few major players. At the end of May, Lithuania’s largest lab supplier was the most recent target of an acquisition, when US lab giant Thermo...

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