This issue of the GaBI Journal contains only a limited number of articles, but these include two scientific very data-rich articles and an interesting and important expose on the use and misuse of products to treat COVID-19 patients. All three articles have potentially major implications for the global struggle to deal with the current COVID-19 pandemic; either with respect to the proper use of biosimilar products to safely reduce COVID-19 related and non-related pharmaceutical expenditures, as well as to the effects of the pandemic on the criminal use and abuse of human and veterinary pharmaceuticals and other products, e.g. disinfectants.
The first Review Article by Dr Lyndsay Davies et al. from Liverpool, UK investigates ‘the quality and in-use stability of the trastuzumab biosimilar ABP 980 (KANJINTI™) in both concentrated multidose bags and following dilution and extended storage in intravenous bags and elastomeric devices, to address the stability requirements of different global pharmacy practices’. The authors present results of their extensive, in-depth evaluation (funded by Amgen) of an important Herceptin® biosimilar product. The data presented should help pharmacies in both resource-rich and resource-poor countries to prepare and administer this important biosimilar product and thereby increase patient access to this product.
The second Review Article by Ms Josette Sciberras et al. from Malta discusses their view of the impact of the European IP framework on accessibility of biological medicines and makes some recommendations on how to improve this access. They suggest ways to potentially mitigate the negative effects on patents, such as increased sharing of knowledge between originator and other companies, developing a less complex patent regulation in Europe and having more transparent prices and costs related to R & D, manufacturing and public funding. They suggest that such changes could allow biosimilars to come to the market earlier thus improve patient access to biological medicines. While (as pointed out by our reviewers) few if any of the suggestions are novel, the vast amount of data collected, analysed and presented could be of use to anyone interested in biosimilar product development, especially for the European market.
The final Review Article by Dr Esteban Ortiz-Prado et al. from Ecuador and the UK describes some aspects of the impact of the COVID-19 pandemic on the use and abuse of biological products, both originator and biosimilars, in Ecuador. The narrative is based on publicly available information, e.g. from newspaper reports and legal proceedings, personal experiences of the authors, as well as data on tocilizumab provided by Welkom Medicamentos de Especialidad. It describes the effect the pandemic had on the use and even criminal abuse of biological products in this resource-poor country. It is likely that the abuses described in this article also occurred in many other resource-poor and resource-rich countries. In the US, certain personalities, and even major political office holders, have either directly promoted or contributed to similar, ongoing misuse of unapproved, ineffective and even dangerous antidotes. What is perhaps most concerning is the promotion by such people of the replacement of scientifically proven products, including biological and generic drug products, by unproven and known or potentially toxic products. In addition to vaccines, there are many biological, generic and repurposed pharmaceutical products that have either already been shown to be useful or are being actively investigated for the treatment of COVID-19 patients.
What happened in Ecuador and what is continuing in the US illustrate how easy and dangerous it can be to return to the promotion and use of unproven and even clearly dangerous ‘snake oil’ cures of the past.
Readers are encouraged to submit similar reports for comparison or comments on the events in the US, Ecuador, or elsewhere.
I want to both thank the GaBI staff, as well as all our authors, reviewers and readers for all you have done to make the GaBI Journal possible. Your continuing hard work and support allows us to pursue the GaBI mission, ‘to foster the worldwide efficient use of high quality and safe medicines at an affordable price, thus advancing and supporting the idea of accessible, affordable and sustainable health care’. Finally, I want to wish you all a healthy, Happy Holiday season and New Year.
Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal
Disclosure of Conflict of Interest Statement is available upon request.
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