Biosimilars in Hematology: Increasing Choice, Expanding Access - European Medical Journal

Biosimilars in Hematology: Increasing Choice, Expanding Access

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Pier Luigi Zinzani1
Joerg Windisch,2 Steffen Thirstrup,3 Wojciech Jurczak,,4 Paul Cornes5

Pier Luigi Zinzani has a financial interest/relationship or affiliation in the form of consultancy for Bayer AG and Sandoz and has participated in speaker bureaus for Celgene International Sàrl, MundiPharma International Ltd, Pfizer Inc., and Takeda Pharmaceutical Company Limited. Pier Luigi Zinzani has received honoraria from and served on scientific advisory boards (SABs) for Celgene International, Sàrl, F. Hoffmann-La Roche Ltd., GlaxoSmithKline, MundiPharma International Ltd, and Takeda Pharmaceutical Company Ltd., and honoraria from Pfizer Inc. and SAB for Bayer AG and Gilead. Joerg Windisch is an employee of Sandoz Biopharmaceuticals. Steffen Thirstrup is a full-time employee at NDA Regulatory Services Ltd., which has a contractual agreement for his participation in this educational session. Wojciech Jurczak has received research funding from Celgene, Eisai, Gilead, Janssen, Pharmacyclics, Pfizer, Roche, Sandoz–Novartis, Spectrum, Takeda, and Teva, and has served on SABs for MundiPharma, Sandoz–Novartis, Spectrum, Takeda, and Teva. Paul Cornes has received salary from the UK NHS and honoraria from Roche, Janssen, Sandoz, Lilly, European Generics Association, Teva, and Hospira.


Writing assistance provided by Dr Tom Priddle, ApotheCom ScopeMedical.


The publication of this article was funded by Sandoz Biopharmaceuticals. The views and opinions expressed are those of the authors and not necessarily of Sandoz Biopharmaceuticals.

EMJ Hema. ;1[1]:30-39. DOI/10.33590/emjhematol/10310005.

Each article is made available under the terms of the Creative Commons Attribution-Non Commercial 4.0 License.

Meeting Summary

Biologicals have revolutionised modern medicine by offering vital therapeutic options to treat or prevent complex, disabling, and life-threatening diseases. Between 2013 and 2018, seven of the top ten pharmaceuticals worldwide will be biologicals; however, growing demand, combined with historically-limited competition, will continue to strain healthcare budgets and limit patient access to these treatments. Since 2006, when the first biosimilar Omnitrope® was approved in Europe, 18 other biosimilars, including the first biosimilar monoclonal antibody (mAb), infliximab (approved in 2013), have received marketing authorisation with many others currently in development. There is now extensive clinical experience with biosimilar epoetin (EPO) and filgrastim in patients with cancer, and many studies have reported comparable efficacy with the originator products, no unexpected safety concerns, and significant economic savings. Nevertheless, misconceptions concerning biosimilars remain. This educational session discussed these issues and gave an overview of biosimilar use in hematology. Dr Joerg Windisch highlighted the particular challenges and considerations associated with the development of biosimilars while Prof Steffen Thirstrup covered the approval of biosimilars from the regulatory perspective. Dr Wojciech Jurczak gave a presentation on the development of biosimilars in hematology, with a particular focus on rituximab from a clinical perspective. Dr Paul Cornes concluded with the opportunities that the introduction of biosimilars offer in terms of health economics and improved patient access to care.

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