Me-too drug: Difference between revisions
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==Examples== |
==Examples== |
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Me-too drugs include [[amitriptyline]], [[paroxetine]], [[diazepam]], [[enalapril]], [[propranolol]], [[atorvastatin]], [[ranitidine]], [[escitalopram]], [[esketamine]] and [[esomeprazole]],<ref name=Aronson/> |
Me-too drugs include [[amitriptyline]], [[paroxetine]], [[diazepam]], [[enalapril]], [[propranolol]], [[atorvastatin]], [[ranitidine]], [[escitalopram]], [[esketamine]] and [[esomeprazole]],<ref name=Aronson/> |
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Several me-toos followed the prototype of the [[ace inhibitor]], [[captopril]]. Most were as efficient as each other and had similar adverse effect profiles.<ref name="Hanekamp2007">{{cite book|last=Hanekamp|first=Gerd |title=Business Ethics of Innovation|url=https://books.google.com/books?id=mjzuHG7g4lcC&pg=PA44|year=2007|publisher=Springer |isbn=978-3-540-72309-7|page=44}}</ref> |
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When Merck's cholesterol-lowering statin [[mevacor]] was approved by the [[Food and Drug Administration]] (FDA) in 1987, the understanding of the link between cholesterol and heart disease was making ground, the potential market for the drug became significant and subsequently several other companies looked into developing similar drugs; Merck's [[zocor]] and [[crestor]], [[Pfizer]]'s [[lipitor]], [[Bristol-Myers Squibb]]'s [[pravachol]], [[Novartis]]'s [[lescol]].<ref name="MAngell2004">{{cite book|last=Angell|first=Marcia |title=The Truth About the Drug Companies: How They Deceive Us and What to Do About It|url=https://books.google.com/books?id=5DKwxAnhTygC|year=2004|publisher=Random House Publishing Group|page=80|isbn=978-1-58836-211-7}}</ref> |
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[[Nexium]] by [[AstraZeneca]] is a me-too which was shown to preserve revenues of the brand [[prilosec]], whose US patent expired in 2001. Considered a new drug by the FDA, nexium was patented separately, sold for eight times the cost of its generic [[esomeprazole]] and advertised as significantly better than its predecessor, a move the company received much criticism for, with a subsequent class action lawsuit filed against them.<ref name="Hanekamp2007"/> |
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==Statistics== |
==Statistics== |
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Revision as of 16:52, 20 July 2020
The term me-too drug or follow-on drug refers to the array of medications that are similar to pre-existing drugs, usually by making minor modifications to the prototype, reflected in slight changes in the profiles of side effects or activity, and used to treat conditions for which drugs already exist.[1][2] While pharmaceutical companies have justified the development of me-toos as offering improvements in efficacy, side-effects, compliance and cost, critics have questioned the increasing marketing of me-toos, their absorption of research and development resources and their impact on the innovation of new treatments.[3][4]
The term follows from the phrase "me too" and is usually used in a negative way, the idea being the me-too drug simply rode the coattails of the research and development done to develop the prototype active pharmaceutical ingredient (API). Me-too drugs can be novel compounds themselves, and drug products containing them can serve as market competition, driving prices down;[3][5] similarly active compounds are exhibited soon after a novel API is made available.[6]
Definition
An agreed definition by consensus does not appear to be reported. However, several have been offered including:
- multiple drugs within the same therapeutic class
- drugs that are chemically related to the prototype, or other chemical compounds which have an identical mechanism of action
- drugs which have more or less identical clinical outcomes to pre‐existing drugs
- a drug with a similar chemical structure or the same mechanism of action as a drug that is already marketed.[7]
Examples
Me-too drugs include amitriptyline, paroxetine, diazepam, enalapril, propranolol, atorvastatin, ranitidine, escitalopram, esketamine and esomeprazole,[7]
Several me-toos followed the prototype of the ace inhibitor, captopril. Most were as efficient as each other and had similar adverse effect profiles.[8]
When Merck's cholesterol-lowering statin mevacor was approved by the Food and Drug Administration (FDA) in 1987, the understanding of the link between cholesterol and heart disease was making ground, the potential market for the drug became significant and subsequently several other companies looked into developing similar drugs; Merck's zocor and crestor, Pfizer's lipitor, Bristol-Myers Squibb's pravachol, Novartis's lescol.[9]
Nexium by AstraZeneca is a me-too which was shown to preserve revenues of the brand prilosec, whose US patent expired in 2001. Considered a new drug by the FDA, nexium was patented separately, sold for eight times the cost of its generic esomeprazole and advertised as significantly better than its predecessor, a move the company received much criticism for, with a subsequent class action lawsuit filed against them.[8]
Statistics
Between 1998 and 2003, the US Food and Drug Administration (FDA) approved 487 drugs, of which 78 per cent appeared to have similar characteristics to pre-existing marketed drugs.[10]
More than 60% of medicines listed on the World Health Organization's essential list are me‐too drugs.[7]
History
The term "me‐too drugs" was coined in the 1950s. In 1956, Louis S. Goodman, co‐editor of Goodman and Gilman, referred to “the problem of the introduction of ‘me too’ drugs, that is, drugs without signal advantage of any sort”.[7] In 1964, Louis Lasagna described me-too drugs as being “hard to justify putting into man at all, let alone on the market”.[7] Three years later, the term appeared in the Oxford English Dictionary.[7] In 1994, Desmond Laurence's textbook Clinical Pharmacology referred to me-too as "me-again".[7]
See also
References
- ^ Buccafusco, Christopher; Masur, Jonathan S. (31 March 2020). "Drugs, Patents, and Well-Being". Rochester, NY.
{{cite journal}}: Cite journal requires|journal=(help) - ^ Vincent Rajkumar, S. (23 June 2020). "The high cost of prescription drugs: causes and solutions". Blood Cancer Journal. 10 (6): 1–5. doi:10.1038/s41408-020-0338-x. ISSN 2044-5385.
- ^ a b Garattini, S. (November 1997). "Are me-too drugs justified?". Journal of Nephrology. 10 (6): 283–294. ISSN 1121-8428. PMID 9442441 – via PubMed.
- ^ Hollis, Aidan (13 December 2004). "Me-too drugs: is there a problem" (PDF). World Health Organization. Retrieved 30 July 2018.
{{cite web}}: CS1 maint: url-status (link) - ^ Patterson, Julie A.; Carroll, Norman V. (1 May 2020). "Should the United States government regulate prescription prices? A critical review". Research in Social and Administrative Pharmacy. 16 (5): 717–723. doi:10.1016/j.sapharm.2019.06.010. ISSN 1551-7411.
- ^ "Glossary Term: Mee-Too Drug". Glossary.pharma-mkting.com. Retrieved 2018-07-30.[dead link]
- ^ a b c d e f g Aronson, Jeffrey K.; Green, A. Richard. "Me-too pharmaceutical products: History, definitions, examples, and relevance to drug shortages and essential medicines lists". British Journal of Clinical Pharmacology. n/a (n/a). doi:10.1111/bcp.14327. ISSN 1365-2125.
- ^ a b Hanekamp, Gerd (2007). Business Ethics of Innovation. Springer. p. 44. ISBN 978-3-540-72309-7.
- ^ Angell, Marcia (2004). The Truth About the Drug Companies: How They Deceive Us and What to Do About It. Random House Publishing Group. p. 80. ISBN 978-1-58836-211-7.
- ^ Angell, Marcia (7 December 2004). "Excess in the pharmaceutical industry". Canadian Medical Association Journal. 171 (12): 1451–1453. doi:10.1503/cmaj.1041594. ISSN 0820-3946. PMID 15583183.
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