Globalization of the world’s economy has clearly created both major advances and ongoing challenges including in the pharmaceutical industry. Naming of pharmaceuticals might seem to be an uninteresting topic to those outside of the pharmaceutical industry. In fact, as I learned many years ago as a volunteer member of the US Pharmacopeia (USP) Nomenclature Committee, nomenclature presents an ongoing, major, unanswered challenge. This is clearly true for biosimilars; as discussed in both the Editorial by our Deputy Editor-in-Chief, Dr Robin Thorpe, and the Review Article by Michael Sarshad et al. to which Dr Thorpe was responding. It is unclear what, when, or whether truly global solution(s) will be found for these (or any of the many other) globalization challenges we face.
Another global problem is of unequal access to medicines. This access can be increased by the savings generated by more rational prescribing. One example is the use of the least expensive effective treatments; especially those used for very common diseases. An Original Research by Godman et al. describes a number of recent, successful initiatives that decreased expenditures by the Scottish healthcare system for proton pump inhibitors (PPIs). The savings are especially impressive because they occurred despite major increases in the total number of PPI prescriptions. While countries, healthcare systems, pricing and payers differ widely the methods and the outcome metrics described both deserve global consideration.
Naming and more rational prescribing are only some of the global harmonization challenges associated with the approval and use of biosimilars and generics, as illustrated by the Gulf Cooperation Council (GCC) Meeting Report by Professor Gianluca Trifirò et al. This report describes the latest in a series of educational meetings organized by the Generics and Biosimilars Initiative (GaBI). These meetings are designed to provide a way for various stakeholders (in this case from GCC, EU and US countries as well as Norway) to discuss best practice approaches to the approval, interchangeability, substitution and post-marketing surveillance of products. Organizers and participants describe the meeting discussions and conclusions. Presentation slides are available on the GaBI website. Readers who are interested in sponsoring similar meetings in their countries or regions are encouraged to contact the GaBI publisher.
Use of generic drugs is unfortunately not always associated with either savings or ethical actions. The 2004–2016 US generic drug market is discussed in an Abstracted Scientific Content Article. This report by the US National Bureau of Economic Research (NBER) was prompted by recent problems with generic drug availability and major price increases. The report summarizes major issues associated with the limiting if not elimination of cost savings associated with the use of generic drugs. The problems discussed concerning generic drug availability, decreasing competition, and costs are threatening patients’ health or even survival. Readers are encouraged to submit articles discussing both the positive and negative aspects of generic drug development and use.
My letter for this last issue of 2018 gives me the opportunity to make some additional comments on the important manuscript by Vieillard et al. published in the previous GaBI Journal issue (Vieillard et al., GaBI Journal. 2018;7(3):101-10).
This Original Research described studies of the extended stability of a trastuzumab biosimilar (CT-P6) after ‘its reconstitution in vials, dilution in polyolefin bags and storage at various temperatures’. Dilution of prepackaged, parenteral products is especially important for paediatric patients where the amount of drug in a single vial is often, if not always, much more than needed to treat a single patient; yet labelling instructions do not advise use of a vial’s contents for multiple patients or even for multiple doses in the same patient. In such cases pharmacists are faced with the option of discarding part or even most of a (very expensive) vial. Potential savings associated with use of a part of a vial for another paediatric patient are unlikely because trastuzumab is an anti-human epidermal growth factor receptor 2 (anti-HER2) antibody used only to treat an adult disease (HER-2 positive breast cancer) and requires use of more than one vial. However, I failed to point out the potential to save costs even in adults, especially in patients requiring reduced dosing; such as those with limited cardiac reserve, but also in any adult where part of a vial is discarded. The magnitude of the potential cost savings is huge because of the costs of some drugs. A recent presentation, for example, estimated that in 28 European countries alone savings associated with the use of this 30% cheaper biosimilar could be as much as Euros 290 million to Euros 562 million (Suh et al. https://tools.ispor.org/ScientificPresentationsDatabase/Presentation/87592). Therefore, even a small decrease in the amount of trastuzumab discarded could have major economic impact. However, enthusiasm for the use of unused or diluted products must be tempered by the fact that even major pharmaceutical firms have faced regulatory good manufacturing practice (GMP) actions because of problems maintaining the sterility of such products. I encourage readers to submit studies which examine both the potential economic benefits as well as risks associated with the on-site manipulation of any parenteral product; both biological and non-biological.
Finally, I and the GaBI staff want to wish our readers, contributors, advisors and editors a happy, productive and healthier New Year.
Professor Philip D Walson, MD
Disclosure of Conflict of Interest Statement is available upon request.
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