3
The term “generic” applies to products containing mostly small molecule chemical active substances, usually produced by chemical synthesis. EU legislation describes a generic product as a product which has the same active substance in the same amount as the originator’s product (the reference product), the same pharmaceutical form, and whose bioequivalence with the reference product has been demonstrated by appropriate bioavailability studies [1]. “Innovative” products in most countries of the world are rewarded and protected from competition in a number of ways, but they are not allowed to keep the market to themselves forever. Generic medicines are basically copies of these innovative medicines which were once new but which have been marketed for several years with proven satisfactory efficacy and safety. The passage of time (10 years in most EU Member States) transforms innovative medicines with new active substances into established medicines, and opens the door to generic competition.
The views expressed in this chapter are the personal views of the authors and may not be used or quoted as being made on behalf of, or reflecting the position of, any national competent authority, the European Medicines Agency (EMA) or one of its committees or working parties.
This is a preview of subscription content, log in via an institution to check access.
Access this chapter
Tax calculation will be finalised at checkout
Purchases are for personal use only
Preview
Unable to display preview. Download preview PDF.
References
The current EU legal definition for generic products is found in Directive 2001/83/EC, Article 10 (2)(b)
Chow S-C, Liu J-P (1992) Design and Analysis of Bioavailability and Bioequivalence Studies. Marcel Dekker Inc., New York
Guideline on the investigation of bioequivalence, CHMP/EWP/QWP/1401/98 Rev. 1,29 January 2010
Endrenyi L, Yan W (1993) Variation of Cmax and Cmax/AUC in investigations of bioequivalence. Int J Clin Pharmacol Therapy Toxicol 31(4): 184–189
The same criteria also apply in the USA and in many other countries worldwide.
Duncan R, Sat Y-N (1998) Tumour targeting by enhanced permeability and retention (EPR) effect. Ann Oncol 9(Suppl 2): 39
Article 10(4) of Directive 2001/83/EC and Section 4, Part II, Annex I to this Directive
Rachel Chu, Meir Pugatch Biogenerics or biosimilars? Discussing the Present, Considering the Future. The Stockholm Network (2009) http://www.stockholm-network.org/downloads/publications/Biosimilars_FINAL.pdf
Schneider CK, Kalinke U (2008) Toward biosimilar monoclonal antibodies. Nature Biotechnol 26: 985–990
Ariëns EJ (1984) Stereochemistry, a basis for sophisticated nonsense in pharmacokinetics and clinical pharmacology. Eur J Clin Pharmacol 26(6): 663–668.
Tucker GT (2000) Chiral switches. Lancet 355: 1085–1087
Waldemar Kaempffert (1936) The week in science: new control for infections. The Chemical Given to F.D. Roosevelt Jr. for Streptococcus Hailed as Important Discovery — New York Times (1857-Current file. New York, N.Y., pp. 1, 24
Vikash Kumar (2008) Me-Too Drugs — A Tiny Revolutionize: Latest Reviews, Vol. 6, Issue 3
Amyes SGB (2001) Magic Bullets Lost Horizons: The Rise and Fall of Antibiotics. Taylor & Francis Inc., London
Goozner M (2004) The $800 Million Pill: The Truth Behind the Cost of New Drugs. University of California Press, Berkley, California, USA, 297 pp. Chapter 8
Silverman MM, Lee PR (1974) Pills, Profits, and Politics, pp. 4–5
Angell M (2004) The Truth about Drug Companies: How They Deceive us and What to Do about It, Random House
Dimasi JA, Paquette C (2004) The economics of follow-on drug research and development: trends in entry rates and the timing of development. Pharmacoeconomics 22(s2): 1–14
Dimasi JA (2001) New drug development in the United States from 1963 to 1999. Clin Pharmacol Ther 69(5): 286–296
Lee TH (2004) “Me-too” products — friend or foe? N Engl J Med 350(3): 211–212
Austin PC, Mamdani MM, Juurlink DN (2006) How many “me-too” drugs are enough? The case of physician preferences for specific statins. Ann Pharmacother 40: 1047–1051
Alastair JJ, Wood MD (2006) A proposal for radical changes in the drug-approval process. NEJM 355(6): 618–623
Eichler HG, Bloechl-Daum B, et al. (2010) Relative efficacy of drugs: an emerging issue between regulatory agencies and third-party payers. Nat Rev Drug Discov 9: 277–291
Furberg C, Herrington D, Psaty B (1999) Are drugs within a class interchangeable. Lancet 354(9185): 1202–1204
http://www.medicine.ox.ac.uk/bandolier/booth/glossary/class.html
McAlister FA, Laupacis A, Wells GA, Sackett DL (1999) Users’ Guides to the Medical Literature: XIX. Applying clinical trial results B. Guidelines for determining whether a drug is exerting (more than) a class effect. JAMA 282(14): 1371–1377
Wang WH, et al. (2005) Head-to-head comparison of H2-receptor antagonists and proton pump inhibitors in the treatment of erosive esophagitis: a meta-analysis. World J Gastroenterol 11(26): 4067–4077
Standard doses of the oral proton pump inhibitors are clinically equivalent: a comparison Alan B. R. Thomson Current GERD Reports 2007, 1: 223–232
NICE Guideline Dyspepsia 23. Aug. 2004
Author information
Authors and Affiliations
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2010 Springer-Verlag/Wien
About this chapter
Cite this chapter
Wade, G., Bloechl-Daum, B. (2010). Generics, biosimilars, enantiomers and me-toos. In: Müller, M. (eds) Clinical Pharmacology: Current Topics and Case Studies. Springer, Vienna. https://doi.org/10.1007/978-3-7091-0144-5_23
Download citation
DOI: https://doi.org/10.1007/978-3-7091-0144-5_23
Publisher Name: Springer, Vienna
Print ISBN: 978-3-7091-0143-8
Online ISBN: 978-3-7091-0144-5
eBook Packages: Biomedical and Life SciencesBiomedical and Life Sciences (R0)