References
- European Generic Medicines Association. 2007 market review: the European generic pharmaceutical markets. European Generic Medicines Association, Brussels, Belgium (2007).
- Directive 2004/27/EC of the European Parliament and of the Council of 31st March 2004 amending Directive 2001/83/EC. Community code relating to medicinal products for human use. Official J. EU34–57 (2004).
- Tse G, Thompson D, Procyshyn RM. Generic clozapine: a cost-saving alternative to brand name clozapine? Pharmacoeconomics21(1), 1–11 (2003).
- Healy DJ, Taylor S, Goldman M, Barry K, Blow F, Milner KK. Clinical equivalence of generic clozapine. Community Ment. Health J.41(4), 393–398 (2005).
- Nuss P, Taylor D, De Hert M, Hummer M. The generic alternative in schizophrenia: opportunity or threat? CNS Drugs18(12), 769–775 (2004).
- IMS Health. IMS lifecycle R&D focus. IMS Health, London, UK (2007).
- Mellstedt H, Niederwieser D, Ludwig H. The challenge of biosimilars. Ann. Oncol.19(3), 411–419 (2008).
- European Generic Medicines Association. EGA Handbook on Biosimilar Medicines. European Generic Medicines Association, Brussels, Belgium (2008).
- Cleemput I, Van Wilder P, Vrijens F, Huybrechts M, Ramaekers D. Guidelines for Pharmacoeconomic Evaluations in Belgium. Health Technology Assessment. Belgian Healthcare Knowledge Centre, Brussels, Belgium (2008).
Websites
- European Medicines Agency. Guideline on similar biological medicinal products. www.emea.eu.int/pdfs/human/biosimilar/043704en.pdf (Accessed 9 October 2008).
- International Society for Pharmacoeconomics and Outcomes Research. Pharmacoeconomic guidelines around the world. www.ispor.org/PEguidelines/index.asp (Accessed 13 October 2008)