This third issue of GaBI Journal in 2018 contains manuscripts which discuss a number of important, post-marketing, ‘real world’ generic and biosimilar medicinal product issues.
In a Commentary, Pitts and Reilly discuss why they believe that unique product names are needed for both generics and biosimilar medicinal products. They discuss the need for consideration of product quality rather than only costs in the use of products and their post-marketing surveillance. Counterfeit amoxicillin products are used as an example of the dangers of substandard products. They call for the World Health Organization (WHO) to finalize its unique product identifier guidelines and argue that use of such unique product identifiers would, ‘increase the accuracy of prescribing and facilitate accurate attribution of adverse events’. They discuss the advantages of such naming. However, some reasons for believing that the benefits of such naming may not be as ‘clear’ as stated are not discussed. For example, generic products have unique names and yet are subject to counterfeiting and substandard products. What is to stop counterfeiters from producing bogus labelling for substandard counterfeit biosimilar products? Healthy skepticism is also justified by the fact (pointed out by the authors, see their reference 11) that even batch numbers can fail to accurately identify products. Finally, even if the product and batch are accurately identified, and found to be associated with a given adverse event, there will still be problems deciding on causation; especially if due to inadequate storage or handling of the product by distributors, pharmacies, clinics, hospitals, physician offices, and/or patients themselves. Despite these underemphasized concerns, it is not possible to argue with their claim that, ‘clarity is better than confusion’. Studies/data are clearly needed that document both the positive and negative results of unique naming initiatives (including costs, confusion, and ‘accuracy’ of prescribing). Readers must also note that there are economic impacts of such naming; including maintaining name recognition or preferential use of innovator products.
The Original Research by Vieillard et al. is an excellent example of the type of ‘real-world’ data needed to more efficiently use biosimilar products. These authors describe an in-depth study done to assess the stability of a diluted trastuzumab biosimilar product. While stability studies are described by both pharmacopeias and regulatory bodies for product registration, they are not required or often performed using concentrations or durations of storage other than those recommended in product labelling. This can result in avoidable waste/costs; especially in populations, e.g. children, where ‘extemporaneous’ dilutions are used. The authors are to be commended for performing the type of ‘academic’ studies needed to assess such extemporaneous preparations. The study also serves as an example of one type of data which need to be considered when assessing post-marketing event reports, such as those collected in patient registries.
The use of such a registry is the subject of an Original Research by Fernández et al. These authors summarize data collected in Argentina for a Bevacizumab biosimilar treatment registry. While providing some useful data not available elsewhere it is important to acknowledge the many limitations of such data. The number of patients is very limited and the data accuracy highly questionable; only in part because of incomplete completion of data forms as mentioned by the authors. There is a body of literature discussing the relative merits of such physician-based registries versus alternatives including mining of electronic medical records or rare disease databases which use patient/parent rather than physician data entry. Assigning causation can also be extremely difficult in patients receiving multiple treatments. Finally, as mentioned above, such databases do not routinely collect information on product handling and storage.
Another Original Research by Alviz-Amador et al. presents the use of in vitro microbiological testing to evaluate two generic antibiotic (amoxicillin) products. The data have potential to improve the acceptance or use of generic drug products by practitioners, health administrators and perhaps even regulators. However, the study raises a number of scientific concerns; only some of which are mentioned in the accompanying Editor’s note. There is a body of literature on the limitations of using microbiological tests such as the minimal inhibitory concentration (MIC) as the sole measure of pharmacodynamic effects on resistant bacterial species. Still, because the MIC can be easily measured even in resource-poor environments and because it is both commonly used and understood by clinicians, it has appeal as a way to overcome practitioner reluctance to prescribe generic drug products. Studies should be done to compare the impact, e.g. physician acceptance and economic, of such testing compared to other methods used to assess or compare products. Despite these somewhat ‘academic’ concerns, the authors are to be congratulated for attempting to find a practical way to compare generic drug products and use the data to promote generic drug use. I encourage the authors to submit follow-up studies on the ‘real world’ impact of distributing the results of such testing.
The Meeting Report by Thorpe et al. summarizes a GaBI organized, first ASEAN educational Workshop held in Thailand in 2017 using the same format used in a number of prior GaBI Workshops to, ‘provide a forum to exchange knowledge on best practice and quality assessment related to biosimilar approval’.
The final Abstracted Scientific Content in this issue provide summaries of two manuscripts published elsewhere which were judged to contain important information of special interest to GaBI Journal readers. The first covers a recent review article by Piatkiewicz et al. published in the online journal Pharmacoeconomics – Open. The authors summarize the history and evolution of Risk Sharing Agreements (RSAs). RSAs are being increasingly used by EU payers, health technology assessment agencies, and pharmaceutical companies in the drug development process. The second is a summary of a review by Roughead et al. published recently in the WHO South East Asia Journal of Public Health. These authors examined changes in atorvastatin prices in four countries as a result of the use of a number of different generic drug price control policies. The results suggest that the use of a mixture of policies may be the most effective way to maximize cost savings from the use of generic drugs.
I and the entire editorial staff hope that our readers find these manuscripts interesting and useful. We also encourage readers to send us any comments, positive or not so positive, on either the manuscripts or the journal as well as to submit their own manuscripts.
Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal
Disclosure of Conflict of Interest Statement is available upon request.
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