In a mini review, author Professor Roy G Beran explains how generics can be produced at a much lower cost than originator drugs [1].
The Oxford English Dictionary defines ‘generic’ as meaning ‘Characteristic of or relating to a class or group of things; not specific: (of goods, especially medicinal drugs) having no brand name, not protected by a registered trademark; lacking imagination or individuality; predictable and unoriginal’ [2]. Despite such essentially derogatory definition, prescription of generics is being mandated in Australia, when using electronic prescriptions [3, 4]. The rationale to enforced use of generic drug prescription of the active ingredients, within a given medication, is to respect economic consideration [5, 6].
The cost, from concept through to formulary inclusion, for any given originator medication, is estimated to be approximately US$2.7 billion [7]. The average time required, from development to marketed medication, is ~7.3 years [7], with a range of between ~6 to >15 years [7], during which time the research and development (R & D) costs are borne by the relevant pharmaceutical company. There has been a concerted effort to reduce the perceived R & D costs to well below this figure of US$2.7 billion [7], but such consideration makes no allowance for the failed development of many conceptual products. More than 90% of chosen molecules, initially tested in animals, fail to proceed to human trials [7]. Those questioning the R & D expenditure often ignore this cost [7], but to do this is often mistaken because, even at the animal testing stage, <10% of potential compounds advance to human trials [8] and, of these, a significant number still fail human trials. All of these costs must be included in the whole range of medications being developed by that R & D pharmaceutical company, to achieve equitable outcomes.
The cost of developing a generic drug competitor, when compared with those costs associated with an originator R & D medicine, is considerably lower than even their sale prices in developed nations would suggest [9], especially if developed in India, the home of many generic drug compounds [9].
Conflict of interest
The author of the research paper [1] declared that there was no conflict of interest.
Abstracted by Professor Roy G Beran, Neurology Department, Liverpool Hospital, Liverpool, Australia.
GaBI Journal Citation Impact
1.9 – CiteScore 2020 (calculated on 5 May 2021)
2.2 – CiteScoreTracker 2021 (Last updated on 6 April 2022)
Submit a manuscript to GaBI Journal
Related articles
What is the meaning of a narrow therapeutic index?
What is meant by a generic medication and generic equivalence?
Consequences of generics being favoured by healthcare providers
Re-evaluation of the use of generics, especially when treating conditions such as epilepsy
| LATIN AMERICAN FORUM The new section of the ‘Latin American Forum’ on GaBI has been launched. The objective of this new section is to provide you with all the latest news and updates on developments of generic and biosimilar medicines in Latin America in Spanish. View last week’s headline article: Nomenclature of biologicals and biosimilars in Peru Browse the news in the Latin American Forum! Register to receive the GaBI Latin American Forum newsletter. Inform colleagues and friends of this new initiative. LATIN AMERICAN FORUM Se ha lanzado la nueva sección del ‘Foro Latinoamericano’ sobre GaBI. El objetivo de esta nueva sección es brindarle las últimas noticias y actualizaciones sobre desarrollos de medicamentos genéricos y biosimilares en América Latina en español. Vea el artículo principal de la semana pasada: Nomenclature of biologicals and biosimilars in Peru !Explore las noticias en el Foro Latinoamericano! Regístrese para recibir el boletín informativo GaBI Foro Latinoamericano. Informe a colegas y amigos sobre esta nueva iniciativa.
|
References
1. Beran RG. Generic substitution in patients whose illness has a narrow therapeutic index, such as epilepsy. APHE. 2020;1(2):1-5.
2. Lexico. Generic. [www.lexico.com]. Oxford, UK: Oxford University Press; [cited 2022 May 27]. Available from: www.lexico.com/definition/generic
3. The Pharmacy Guild of Australia. Electronic prescriptions – ePrescriptions update - 7 December 2020 [homepage on the Internet]. [cited 2022 May 27]. Available from: www.guild.org.au/guild-branches/nsw/guild-clinical/electronic-prescriptions#:~:text=ePrescriptions%20Update%20%2D%207%20December%202020,the%20capability%20to%20issue%20ePrescriptions
4. Australian Government. Department of Health. Electronic prescribing [homepage on the Internet]. [cited 2022 May 27]. Available from: www.health.gov.au/initiatives-and-programs/electronic-prescribing
5. Straka RJ, Keohane DJ, Liu LZ. Potential clinical and economic impact of switching branded medications to generics. Am J Ther. 2017;24(3):e278 89.
6. Dunne S, Shannon B, Dunne C, et al. A review of the differences and similarities between generic drugs and their originator counterparts, including economic benefits associated with usage of generic medicines, using Ireland as a case study. BMC Pharmacol Toxicol. 2013;14:1.
7. Prasad V, Mailankody S. Research and development spending to bring a single cancer drug to market and revenues after approval. JAMA Intern Med. 2017;177(11):1569-75.
8. Akhtar A. The flaws and human harms of animal experimentation. Camb Q Healthc Ethics. 2015;24(4):407-19.
9. Hill AM, Barber MJ, Gotham D. Estimated costs of production and potential prices for the WHO Essential Medicines List. BMJ Glob Health. 2018;3(1):e000571.
Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing.
Copyright – Unless otherwise stated all contents of this website are © 2022 Pro Pharma Communications International. All Rights Reserved.
0
Post your comment