New insights into the amount of R & D for new uses of generic drugs

Generics/Research | Posted 12/12/2022 post-comment0

Generic drugs are considered indispensable to healthcare systems because they are substantially cheaper than original versions of the drugs.  These drugs have become common place, within healthcare delivery, because of the anticipated financial benefits [1].

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So far, critics on both sides of the North Atlantic claim that the availability of generics carries a significant detriment: that research on new uses of the compounds (commonly known as ‘repurposing’) becomes financially unviable and, therefore, significantly slows or stops. These claims build on challenges obtaining and enforcing intellectual property (IP), and the critics argue law reform is necessary to encourage more R & D.

A study carried out by Liddicoat et al. [2] was designed to empirically examine this claim by analysing records of clinical trials (phase II and III) for the 15 drugs that had generics introduced for the first time in the US in 2014. Significantly, the study distinguished between trials for new conditions [2] and analysed the number of clinical trials five years after the generics were authorized. The study found that once generics are authorized commercial trials continue at ‘active’ rates for approximately half of the drugs studied, and the number of hospital and university trials in fact increased [3].

Commentary on how to increase the number of repositioned drugs typically focuses on reform to IP and pharmaceutical law. The findings on commercial trials findings cast doubt on whether additional incentives are needed, especially in light of an earlier study that showed an IP incentive for repurposing failed to increase the number of repurposed drugs [4]. The findings on hospital and university trials also indicated that perhaps a more effective way to reposition drugs is for recently established government programmes to leverage the hospital and university trials as an R & D pipeline. Certainly, this study indicated these programmes could be more ambitious, building on the fact that in the five years after generic authorization, hospitals and universities conduct more trials than the originators did during the most prolific five-year period before the generics were authorized. Though, the programmes would encounter several challenges if they attempted to do this. The study outlined three of those challenges and, amongst other things, proposed the programmes use IP strategies demonstrated by companies in the study to help fund their trials and attract partners. 

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, especially if developed in India, the home of many generic drug compounds [5].

Conflict of interest
The author of the research paper [3] declared that there was no conflict of interest. 

Abstracted by Dr John Liddicoat, Senior Lecturer, The Dickson Poon School of Law. King’s College London, UK

Editor’s Comment
Readers interested to learn more about the uses of generic drugs are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Repurposing non-oncology drugs for cancer treatment

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References
1. GaBI Online - Generics and Biosimilars Initiative. Consequences of generics being favoured by healthcare providers[www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 9]. Available from: www.gabionline.net/generics/research/consequences-of-generics-being-favoured-by-healthcare-providers
2. Liddicoat J, Liddell K,  Fritz Z. Reconsidering repositioning incentives: an empirical legal analysis of market protection for new therapeutic indications. Eur Pharm Law Rev. 2021;5(3):110-22.
3. Liddicoat et al, ‘Repositioning Generic Drugs: Empirical Findings and Policy Implications’ (2022) 53 International Review of Intellectual Property and Competition Law 8.
4. Liddicoat et al, ‘Has the EU Incentive for Drug Repositioning Been Effective? An Empirical Analysis of the “+1” Regulatory Exclusivity’ (2021) 52 International Review of Intellectual Property and Competition Law 825.
5. GaBI Online - Generics and Biosimilars Initiative. The cost of developing drugs and the use of generics [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2022 Dec 9]. Available from: www.gabionline.net/generics/research/the-cost-of-developing-drugs-and-use-of-generics

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