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

Brian Godman, Michael Wilcock, Andrew Martin, Scott Bryson, Christoph Baumgärtel, Tomasz Bochenek , Winne de Bruyn, Ljiljana Sović-Brkičić, Marco D’Agata, Antra Fogele, Anna Coma Fusté, Jessica Fraeyman, Jurij Fürst, Kristina Garuoliene, Harald Herholz, Mikael Hoffmann, Sisira Jayathissa, Hye-Young Kwon, Irene Langner, Marija KalabaEva Andersén Karlsson, Ott Laius, Vanda Markovic-Pekovic, Einar Magnusson, Stuart McTaggart, Scott Metcalfe, Hanne Bak Pedersen, Jutta Piessnegger, Anne Marthe Ringerud, Gisbert W. Selke, Catherine Sermet, Krijn Schiffers, Peter Skiold, Juraj Slabý, Dominik Tomek, Anita Viksna, Agnes Vitry, Corinne Zara, Rickard E Malmström

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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.
Original languageEnglish
Pages (from-to)125-135
Number of pages11
JournalGenerics and Biosimilars Initiative journal
Volume4
Issue number3
Early online date7 Sep 2015
Publication statusPublished - 2015

Keywords

  • health authorities
  • generics
  • lyrica
  • pregabalin

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