Affordability and access. Two simple words that nevertheless convey the complex burdens facing many healthcare systems around the world. And within the healthcare realm, there is likely no aspect that embodies issues related to affordability and access more than prescription medicines.
In the twentieth century, where small molecule drugs reigned supreme, the advent of generics brought forth lower-priced options; cost savings were realized and more patients than before were able to benefit from important classes of molecules like statins. As our understanding of molecular biology grew, so did our ability to add more complicated (and much larger) molecules to the armamentarium. The rise of biologicals – complex molecules produced from living organisms and/or tissues – ushered in a new and exciting era of treatments and cures, while also scaling new heights in drug prices.
When biosimilars arrived on the scene in the early 2000s, the hope was that they could do for biologicals what generics did for small molecules. However, while the idea of a generic drug is fairly easy to understand (they are, after all, structurally identical to the originator), the nature of biologicals meant that exact replicas would be essentially impossible to produce. Because of this, an entirely new regulatory scheme was developed to manage the approval of biosimilars, where the focus was much more on analytical demonstrations of similarity than on clinical trials. Layered on top of that was the concept of extrapolation, whereby approval for biosimilar use in a given indication could be based on clinical study data in an entirely different indication. When all these intricacies are combined, it should not be surprising that early attitudes of clinicians towards biosimilars were lukewarm, at best.
The adoption of any new technology requires a period of familiarization and, in their article, authors from Cardinal Health discuss the importance of education to biosimilars uptake [1]. Surveys of clinicians across many specialties consistently indicated several areas where education was needed [2]. In addition to wanting to better understand the aforementioned novel regulatory pathways and concept of extrapolation, clinicians were also in search of information regarding safety, efficacy, and immunogenicity of biosimilars. The years that followed the initial approvals of biosimilars offered important lessons about the link between education and uptake. Regions like the European Union (EU), which placed much more emphasis and effort on educational strategies aimed at healthcare providers (HCPs) [3], saw adoption rates increase as confidence in biosimilars grew. By contrast, the inverse situation was observed in the US, where educational levels regarding biosimilars, and their uptake, have lagged behind those of the EU.
HCP understanding of, and confidence in, biosimilars also impacts patient perception of this class of therapeutics given the immense level of trust the latter place in the former. And this will not only affect patient compliance, but potentially help blunt the nocebo effect*, which is thought to be responsible for some fraction of negative treatment outcomes with biosimilars.
While education is not the only factor impacting biosimilars adoption, it is an important contributor, and one that all healthcare stakeholders should strive to contribute towards. The authors conclude by offering a number of action-items aimed at all relevant populations, not just HCPs, with the goal of improving biosimilar understanding and, ultimately, uptake.
*The nocebo effect is the opposite of the placebo effect. It describes a situation where a negative outcome occurs due to a belief that the intervention will cause harm. It is a sometimes-forgotten phenomenon in the world of medicine safety. The term nocebo comes from the Latin ‘to harm’.
Conflict of interest
The authors of the research paper [1] reported conflict of interest, including being an employee of Cardinal Health, whose clients include pharmaceutical companies. For full details of the authors’ conflict of interest, see the research paper [1].
Abstracted by Ms Sonia Tadjalli Oskouei, PharmD, BCMAS, DPLA, Cardinal Health, Dublin, Ohio, USA.
Editor’s comment
Readers interested to learn more about education for biosimilars are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Local policies on biosimilars: are they designed to optimize use of liberated resources?
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References
1. Oskouei ST, Kusmierczyk AR. Biosimilar uptake: the importance of healthcare provider education. Pharmaceut Med. 2021;35(4):215-24.
2. GaBI Online - Generics and Biosimilars Initiative. Biosimilars education still needed for US and EU clinicians [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/biosimilars/research/Biosimilars-education-still-needed-for-US-and-EU-clinicians
3. GaBI Online - Generics and Biosimilars Initiative. Education for biosimilars in Europe and the US [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2021 Dec 17]. Available from: www.gabionline.net/reports/Education-for-biosimilars-in-Europe-and-the-US
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