What to look forward to in GaBI Journal, 2021, Issue 2

The current pandemic has greatly amplified the already existing disparities in access to health care. Many countries are facing a lack of access to or funding to pay for the vaccines, medications, protective equipment, and supplies; even oxygen to deal with either COVID-19, wars, famine, and other life-threatening conditions. Patients, families and governments are all looking for ways to stretch their healthcare budgets to deal with these realities while faced with pandemic associated decreases in income and tax revenues. Finding ways to increase the use of generic and biosimilar therapeutics could provide at least a partial solution. However, as demonstrated by manuscripts in this as well in many previous GaBI Journal issues, the use of generics, biosimilars and other follow-on biologicals continues to generate only a small portion of what is possible. Manuscripts in this issue deal directly or indirectly with some of the many reasons for this economic underperformance including: a) the high costs associated with developing and marketing follow-on products; b) practitioners’ resistance to prescribing them; c) patients’ resistance to their use; and d) the failure of some governments and even some non-governmental payors to use every tool at their disposal to increase the use and decrease the cost of both originator as well as generic and biosimilar products.

The first Original Research by Kelly Canham and Claire Newcomb (both employees of Viatris/Mylan Pharma UK Ltd, the manufacturer of the product studied) used a simulation study design to evaluate the ability of study patients, caregivers and healthcare providers (HCPs, N = 79) to successfully use an autoinjector to deliver two doses of an etanercept biosimilar into a foam pad. While not stressed by the authors, simulations have the advantage of being much less expensive than clinical trials to perform. In addition, the inclusion of both patients and HCPs can decrease marketing costs while decreasing both patient and provider resistance to switching.

In the second Original Research, Somaily et al. describe the clinical outcomes in a small group of patients with rheumatological disorders in Saudi Arabia who switched from the originator infliximab to a biosimilar. The patients included 6 with rheumatoid arthritis (RA), 5 with ankylosing spondylitis (AS), and 2 with Behçet’s disease (BD) who were, ‘required to switch to the biosimilar version due to the originator becoming unavailable’. One year after the switch, the authors, ‘did not observe any significant differences in tolerability or efficacy between biosimilar and originator. Furthermore, disease activity significantly declined in RA patients following biosimilar treatment’. While limited by the small sample size, such ‘real-life’ studies can be useful to overcome clinician and patient’s biosimilar resistance.

The third Original Research by Godman et al. presents the large volume of data the authors collected concerning prices reimbursed by European countries between 2013 and 2017 for three oral oncology medicines (imatinib, erlotinib and fludarabine). The authors also examined how often prices were re-evaluated both before and after the introduction of generic versions. Prices varied widely in the European countries studied and there was limited price erosion over time in the absence of generics. The authors found no correlation between population size and price, infrequent re-evaluation of prices even when generics were introduced, and that prices of on-patent oral cancer medicines were higher in countries with higher gross domestic products per capita. The authors failed to find evidence of re-assessments of the ‘price, value and place in treatment of patented oncology medicines following the loss of patent protection of standard medicines’ and speculate that the use of such reassessments could be more effectively used as a negotiating tactic to ‘positively impact global expenditures for oncology medicines’. While the evidence provided by the authors’ hypothesis is largely anecdotal, and while failure to find evidence of reassessments does not necessarily mean there were none done, clearly there is a need to more effectively use generic oncology medicines to lower prices paid/charged for these drugs. The authors’ call for continual reassessment of the value (cost per benefit gained) of these drugs is clearly logical and worth exploring.

The first Review Article by Zuccarelli et al. discusses the European Union (EU) regulatory framework and emerging trends in biosimilar drug development. The authors examined all EU marketing authorization applications prior to December 2019. They noted an ongoing evolution in the authorization processes over time as well as a steady increase in total clinical trials, but a steady decrease in the average number of trials per approved product. They also noted that products have been approved without requiring completion of any phase III clinical trial. Finally, no safety concerns were raised by their analysis of adverse event reports. These findings, if properly disseminated, might be useful to counter biosimilar hesitancy.

The second Review Article by Farhang Rezaei and Nassim Anjidani presents an overview of follow-on biological products in Iran. The authors found that while there has been a significant increase in the use of biological products in Iran, their proportional use compared to the total therapeutic market has recently remained constant. The authors conclude that Iranian patients’ access to life-saving biological medicines could be greatly improved if the use of follow-on, rather than originator, biologicals was increased. While Iran is facing many unfortunate geopolitical barriers, it is not the only country where use of follow-on and true biosimilar products is suboptimal. This underutilization decreases the savings generated and then used to pay for increased overall patient access to health care. Solutions are clearly needed to this problem globally.

The final Abstracted Scientific Content summarizes an article by Zhang et al. published in 2020 that reviewed the potential use of already approved (for other indications) non-oncology drugs for clinical cancer management. While there is clearly potential in this approach, this could also result in prolonged exclusivity, patent protection, and increased rather than decreased healthcare costs. The repurposing approach to drug development is more common than appreciated. It has been estimated that approximately 25% of the pharmaceutical industry’s income is generated by repurposed drugs [1, 2]. This topic is worthy of extensive discussion. Readers with expertise in this should consider submitting manuscripts dealing with such drug repurposing, also called repositioning, reprofiling, indication expansion, and indication shift.

All the suggestions mentioned in this issue, as well as others, are likely to be needed if the full potential of follow-on therapeutics to decrease healthcare costs are to be achieved. This could be an important step in slowing or reversing the growth in global disparities in access to health, food and all other basic human needs.

References
1. Naylor S, Kauppi MJ, Schonfeld JM. Therapeutic drug repurposing, repositioning and rescue part II: business review. Drug Discov World. 2015;16(2):57-72.
2. Talevi A, Bellera CL. Challenges and opportunities with drug repurposing: finding strategies to find alternative uses of therapeutics. Expert Opin Drug Discov. 2020;15(4):397-401.

Professor Philip D Walson, MD
Editor-in-Chief, GaBI Journal

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