Biological medicines, generally referred to as ‘biologics’ are responsible for some of the most promising innovations in the treatment of cancer, including immunotherapy, targeted drugs and vaccines. However, these novel therapeutics are also expensive.

According to a report published by IQVIA Institute for Human Data Science, Europe-wide spending in cancer therapeutics exceeded 24 billion euros in 2016, with biological medicines accounting for almost 40% of the expense.

Biosimilars vs. generic drugs
In contrast, biosimilars are therapeutic agents that are highly similar to the original, approved, reference drugs but are not identical. In general, these agents are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. Generally, there are no clinically meaningful differences between the biosimilar and the reference drugs.

Biosimilars is not considered a generic version of a biological agent. This is mostly due to the fact that the natural variability and more complex manufacturing of biological medicines do not allow the exact replication of the molecular micro-heterogeneity.

Savings
According to some estimates, the introduction of biosimilar agents for the top three oncology drugs will result in up to 2 billion euros in savings across Europe in 2021 alone.

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As such, the use of these agents could increase the availability of innovative therapies for patients who would otherwise not be treated with biologicals due to economic constraints. However, to be successful, this approach requires a broader understanding of biosimilars vs. the original reference drug throughout the oncology ecosystem.

Accelerated growth
Since the approval by the European Commission of legislation covering biosimilars (EU Directive 2001/83/EC), 59 biosimilar marketing authorisation applications, 39 of which were approved and marketed (corresponding to 25 distinct biosimilars) were reviewed by the European Medicines Agency. And the submission for approval of novel biosimilars is accelerating. In 2017 alone 14 new molecules were approved, compared to no more than five annual approvals since 2006.

The number of novel biosimilars is also increasing in oncology and hematology. In 2017, oncology biosimilars already approved by the EMA included 6 rituximab biosimilars, 1 bevacizumab and 1 trastuzumab, and of the 15 marketing applications under consideration that year, 3 are for trastuzumab biosimilars.

ESMO’s Position
The European Society for Medical Oncology (ESMO) has previously taken a position on the use of biosimilars [1]. The organization supports their use in oncology as they represent cheaper alternatives to reference biologics with the potential to make optimal cancer care more sustainable and widely accessible.

To further drawing attention to the use of biosimilars vs. the original reference drugs, the European Society for Medical Oncology recently published a paper about the integration of biosimilars into routine oncology practice.[2]

Photo 1.0: Josep Tabernero, MD, PhD, is currently Head of the Medical Oncology Department at the Vall d?Hebron Barcelona Hospital Campus, Director of the Vall d?Hebron Institute of Oncology (VHIO), and leads the Research Innovation of Catalonian Cancer Centers Network. As the current president of the European Society for Medical Oncology he is a member of the ESMO Executive Board.

In the paper ESMO calls for multidisciplinary collaboration to build additional confidence wherever it is still lacking. According to preliminary results of an ESMO-survey to be published later this year, oncologists exhibited only a moderate confidence in their understanding of key concepts that underpin biosimilar drug development and use.

Nearly 87% of the respondents stated that would appreciate additional (continued) education covering biosimilars.

These outcomes clearly confirm that are looking for additional education in relation to biosimilars. These outcomes also confirm that there is a clear need for scientific data and guidance, prerequisites for an accurate and informative discussion with their patients.

Eradicating misconceptions
The same conclusion was reached during an ESMO-moderated discussion at the fourth stakeholder conference on biosimilar medicines, organized by the European Commission in Brussels in September 2018.

?Collaboration and multi-stakeholder approaches to improve understanding and eradicate misconceptions are important for the successful uptake of biosimilars in oncology,? said Josep Tabernero, ESMO President.

?If more education is what oncologists need, being the Society of reference that looks after their professional development, we must urgently act on that,? he added.

At a session on biosimilars during the ESMO 2017 Congress in Madrid, physicians, but also nurses, pharmacists, patient organizations and competent authorities from the European Member States were invited to join the discussion.

?All of [the participants] play a crucial role in delivering these medicines to patients and making sure the latter accept and adhere to their therapies,? Tabernero said.

A similar approach will be proposed at this year?s annual meeting – ESMO 2018 – held in in Munich, Germany.

Biosimilars vs. Reference Drugs
Extrapolating the use of a specific biosimilar in all indications approved for the reference drug appears the most common source of misunderstanding among physicians, nurses and patients alike, according to data in the ESMO survey.

?It is a very difficult concept to explain outside of the regulatory setting,? explained Elena Wolff-Holz from European Medicines Agency, first author of the paper and panel member at the event in Brussels.

?This is what educational initiatives should focus on ? not just for oncologists, but for all healthcare professionals and for patients,? Tabernero, who also co-authored the paper, highlighted.

?The Information Guide for Healthcare Professionals on Biosimilars in the EU has been publicly available since its release in 2017,? Tabernero said.

?It is the product of a concerted effort by the European Commission, the European Medicines Agency,as well as scientific experts, healthcare professionals and patients from the member states ? and of course ESMO, which ensured that the information needs for the oncology community were also adequately addressed. This is exactly the kind of broad-spectrum collaboration we need to see more of going forward.? [3]

References
[1] Tabernero J, Vyas M, Giuliani R, Arnold D, Cardoso F, Casali PG, Cervantes A, Eggermont AM, et al. Biosimilars: a position paper of the European Society for Medical Oncology, with particular reference to oncology prescribers. ESMO Open. 2017 Jan 16;1(6):e000142. doi: 10.1136/esmoopen-2016-000142 [Article][Pubmed]
[2] Wolff-Holz E1, Garcia Burgos J2, Giuliani R3, Befrits G4, de Munter J5, Avedano L6, Aitken M7, et al. Preparing for the incoming wave of biosimilars in oncology. ESMO Open. 2018 Sep 5;3(6):e000420. doi: 10.1136/esmoopen-2018-000420.[Article][Pubmed]
[3] Biosimilar medicines. Human regulatory. Overview. European Medicines Agency (Online). Last accessed October 20, 2018.


Last Editorial Review: October 20, 2018

Featured Image: White pills spilling from medicine bottle on European Union flag. Courtesy: ? 2010 ? 2018 Fotolia. Used with permission. Photo 1.0: Josep Tabernero, MD, PhD, is currently Head of the Medical Oncology Department at the Vall d?Hebron Barcelona Hospital Campus, Director of the Vall d?Hebron Institute of Oncology (VHIO), and leads the Research Innovation of Catalonian Cancer Centers Network. As the current president of the European Society for Medical Oncology he is a member of the ESMO Executive Board. Courtesy: ? 2018 European Society for Medical Oncology. Used with permission.

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