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Generic pregabalin : current situation and implications for health authorities, generics and biosimilars manufacturers in the future

Godman, Brian and Wilcock, Michael and Martin, Andrew and Bryson, Scott and Baumgärtel, Christoph and Bochenek, Tomasz and de Bruyn, Winne and Sović-Brkičić, Ljiljana and D’Agata, Marco and Fogele, Antra and Fusté, Anna Coma and Fraeyman, Jessica and Fürst, Jurij and Garuoliene, Kristina and Herholz, Harald and Hoffmann, Mikael and Jayathissa, Sisira and Kwon, Hye-Young and Langner, Irene and Kalaba, Marija and Karlsson, Eva Andersén and Laius, Ott and Markovic-Pekovic, Vanda and Magnusson, Einar and McTaggart, Stuart and Metcalfe, Scott and Bak Pedersen, Hanne and Piessnegger, Jutta and Ringerud, Anne Marthe and Selke, Gisbert W. and Sermet, Catherine and Schiffers, Krijn and Skiold, Peter and Slabý, Juraj and Tomek, Dominik and Viksna, Anita and Vitry, Agnes and Zara, Corinne and Malmström, Rickard E (2015) Generic pregabalin : current situation and implications for health authorities, generics and biosimilars manufacturers in the future. Generics and Biosimilars Initiative journal, 4 (3). pp. 125-135. ISSN 2033-6403

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Abstract

The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain: its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, generics could be legally prescribed for any approved indication once one indication loses its patent. We aim to establish the current situation with pregabalin among principally European countries. Personnel from 33 regional and national health authorities mainly from Europe, and nine from universities across Europe working as advisers to health authorities or with insight into their activities, were surveyed regarding four specific questions via email to shed light on the current situation with Lyrica and pregabalin in their country. The information collated from each country was subsequently checked for accuracy with each co-author by email and face-to-face contact and collated into five tables. The scenarios ranged from extending the patent life of Lyrica (e.g. France), endorsing the prescribing of Lyrica for neuropathic pain (e.g. Catalonia and South Korea), and current prescribing of pregabablin for all indications (e.g. Serbia and Germany). Little activity has taken place in European countries in which generic pregabalin is not yet reimbursed. The availability of generic pregabalin has prompted a number of different activities to be undertaken among the 33 countries and regions surveyed. The situation in Serbia and the historic situation in Germany provide examples of ways to maximize savings once a product loses its patent for at least one indication.