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Drugs

, Volume 79, Issue 15, pp 1609–1624 | Cite as

Are Biosimilars the Future of Oncology and Haematology?

  • Pier Luigi Zinzani
  • Martin Dreyling
  • William Gradishar
  • Marc Andre
  • Francisco J. Esteva
  • Suliman Boulos
  • Eva González Barca
  • Giuseppe CuriglianoEmail author
Leading Article
  • 125 Downloads

Abstract

Biological drugs are vital but often high-cost components of cancer treatment. Several biosimilar versions of these drugs have been approved in Europe and/or the USA, with many more in development. However, there is some disconnect between the biosimilars that are approved for use and those accessible in clinical practice, with availability impacted by factors including patent litigation and complex healthcare insurance policies, particularly in the USA. Provided the barriers to widespread uptake can be overcome, biosimilars offer potential benefits including cost savings and improved patient access versus the reference product (RP). This article provides an up-to-date and focused perspective on the development and use of biosimilars in the haemato-oncology setting. European and US regulatory pathways governing biosimilar licensing demand that there are no clinically meaningful differences between a biosimilar and its RP. Pathways are rigorously enforced and involve comprehensive non-clinical evaluations and clinical trials in selected indications to establish the equivalence or non-inferiority of efficacy, and the comparability of safety, of the biosimilar versus its RP. ‘Indication extrapolation’ is only permitted if scientifically justifiable considering mechanism(s) of action, pharmacokinetics, immunogenicity and safety in relevant patient populations. Switching treatment from RP to biosimilar is supported by most available data, predominantly from indications other than cancer, and post-marketing pharmacovigilance programmes are warranted. Notably, the potential benefits of biosimilar cancer treatment may extend beyond direct cost savings: for example, the availability of biosimilars of common regimen components may help incentivise the evaluation and/or clinical use of new treatment approaches and novel drugs.

Notes

Acknowledgements

Medical writing support (including development of a draft outline and subsequent drafts in consultation with the authors, assembling tables and figures, collating author comments, copyediting, fact checking and referencing) was provided by Emma Evans PhD, CMPP and Rick Flemming PhD, CMPP at Aspire Scientific Limited (Bollington, UK), and funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). Drafts of the manuscript were reviewed by Dasom Choi at Celltrion Healthcare Co., Ltd.

Compliance with Ethical Standards

Funding

Medical writing support was funded by Celltrion Healthcare Co., Ltd (Incheon, Republic of Korea). The final decision to submit was that of the authors.

Conflict of interest

PLZ has received honoraria from Janssen, Servier, Bristol-Myers Squibb, Merck, Celgene, Roche, Gilead; and has participated in advisory boards for Janssen, Servier, Bristol-Myers Squibb, Merck, Celgene, Roche, Gilead, Celltrion, Portola, Immune Design, TG Therapeutics. MD has received speaker honoraria from Bayer, Celgene, Gilead, Janssen, Roche; research support from Celgene, Janssen, Mundipharma, Roche (to institution); and has participated in advisory boards for Acerta, Bayer, Celgene, Gilead, Janssen, Mundipharma, Roche, Sandoz. WG has participated in independent data monitoring committees for Genentech and Seattle Genetics, and study steering committees for PUMA and AstraZeneca. MA has received research grants from Roche, Amgen, Johnson & Johnson, Novartis, Takeda Millénium, Chugai, Celgene, CAF-DCF Belgian Red Cross; travel grants from Roche, Bristol-Myers-Squibb, Amgen, Celgene; and has participated in advisory boards for Takeda, Bristol-Myers Squibb, Karyopharm, Gilead, Novartis. FJE has received research grants from Novartis, Pfizer, Genentech/Roche, Eli Lilly and Merrimack; has received consultancy fees from Celltrion Healthcare, Pfizer, Novartis, Genentech/Roche, Nanostring, AstraZeneca, Seattle Genetics and Celgene; and has received fees for participation in advisory boards for Celltrion Healthcare, Novartis and Genentech/Roche. SB was employed by Celltrion Healthcare Co. Ltd (Incheon, Republic of Korea) during preparation of this article, and is currently employed at the Shaare Zedek Medical Center, Israel. EGB has received consultancy fees from Janssen, Sandoz, Gilead; and speaker honoraria from F. Hoffmann-La Roche, Janssen, AbbVie. GC has received honoraria from Pfizer, Novartis, Lilly, Roche; fees for expert testimony and medical education from Pfizer; and has participated in advisory boards for Pfizer, Roche, Lilly, Novartis, Seattle Genetics, Celltrion.

Data availability

Data sharing not applicable to this article as no datasets were generated or analysed during the current study.

Ethical approval

This article does not contain any studies with human participants or animals performed by any of the authors.

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • Pier Luigi Zinzani
    • 1
  • Martin Dreyling
    • 2
  • William Gradishar
    • 3
  • Marc Andre
    • 4
    • 5
  • Francisco J. Esteva
    • 6
  • Suliman Boulos
    • 7
  • Eva González Barca
    • 8
  • Giuseppe Curigliano
    • 9
    • 10
    Email author
  1. 1.Institute of Hematology“Seragnoli” University of BolognaBolognaItaly
  2. 2.Medizinische Klinik III, Klinikum der Universitat Munchen, LMU MunichMunichGermany
  3. 3.Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of MedicineChicagoUSA
  4. 4.Universite Catholique de Louvain, CHU UCL NamurYvoirBelgium
  5. 5.Pôle de Recherche Mont, Institut de Recherche Expérimentale et Clinique, Université Catholique de LouvainYvoirBelgium
  6. 6.Perlmutter Cancer Center at NYU Langone HealthNew YorkUSA
  7. 7.Hemato-Oncology Inpatient DepartmentShaare Zedek Medical CenterJerusalemIsrael
  8. 8.Institut Català d’OncologiaIDIBELL, Hospitalet de LlobregatBarcelonaSpain
  9. 9.Department of Oncology and Hemato-OncologyUniversity of MilanoMilanoItaly
  10. 10.European Institute of Oncology, IRCCSMilanoItaly

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