First generic drug to seek pan-European approval gets the go-ahead.
The European Medicines Agency’s Committee for Medicinal Products for Human use (CHMP) has recommended the approval of a schizophrenia treatment which is the first generic drug to be assessed under Europe’s centralised procedure.
This procedure, managed by the EMEA, allows drug makers to have their products assessed by a single centralised process, in order to reach the European market more quickly.
Previously, all drugs companies had to request approval of their products from each individual European country, via what the EMEA refers to as the mutual recognition procedure.
Although the EMEA’s centralised scheme was introduced in 1996, generics manufacturers have had to wait for pharmaceutical company patents to expire before seeking approval for their own versions of the drug.
The first medication to be assessed is a schizophrenia drug, Zalasta (olanzapine), produced by Slovenian generics firm Krka. Zalasta is a version of Eli Lilly’s Zyprexa.
Only certain products are considered for centralised assessment, including innovative biotechnology products and drug treatments for diseases of major public health concern, including HIV, cancer and neurodegenerative diseases.
The EMEA expects an increasing number of applications from makers of generics, as patents for centrally approved products expire. The agency forecasts eight more generic applications for 2007.
Monika Benstetter from EMEA told Chemistry World that the aim of the process was to coordinate all of the best scientists and resources in the EU. ’It was designed to improve access to medicines for patients and will now improve patient access to generics that meet the same criteria,’ she said.
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