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European perspective on biosimilars Posted 27/10/2017

In the European Union (EU), a legal framework for approving biosimilars was established in 2003. The first biosimilar Omnitrope (somatropin) was approved in 2006 [1].

The European Medicines Agency (EMA) was the first regulatory agency to establish guidelines for off-patent biologicals and introduced the concept of biosimilarity [2]. This can be defined as the property of a medicine to show similarity and lack of significant differences in terms of quality, efficacy and safety to a reference biological medicine to which it has been compared [3].

According to oncologist Professor Håkan Mellstedt, ‘the reason for the introduction of a biosimilar is to reduce cost, not to produce a better version of the biologic[al]’ [4]. He points to haematopoietic growth factor biosimilars as an example. Although in the beginning there was low acceptance in the European community ‘today, 80% to 100% of all h[a]ematopoietic growth factors in the various Member States of the European Union are biosimilars’. The reason for the increased uptake, according to Mellstedt, is ‘multifactorial’. Reasons include that: Physicians are better educated about biosimilars, national regulatory authorities and government/regional healthcare providers promote biosimilars and national professional societies favour them.

It is therefore important to get professional bodies on board when it comes to biosimilars. In January 2017, the European Society of Medical Oncology (ESMO) published a position paper about biosimilars [5]. However, although this paper says that ‘biosimilars create opportunities for sustainable cancer care’ and tries ‘to mitigate important issues’, according to Mellstedt, it ‘did not take a strong standpoint’. However, he adds that ‘in the digital publication ESMO Perspectives [6], the introduction of biosimilars was favoured as long as concerns – provision of adequate information to the patient, acknowledgement that indications are extrapolated, and access to resources to adhere to a risk management plan – were addressed’.

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1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe
2. GaBI Online - Generics and Biosimilars Initiative. EU guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Guidelines/EU-guidelines-for-biosimilars
3. GaBI Online - Generics and Biosimilars Initiative. Glossary of key terms [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/General/Glossary-of-key-terms
4. Mellstedt H. European perspective on biosimilars. J Oncol Pract. 2017;13(9_suppl):15s-16s.
5. GaBI Online - Generics and Biosimilars Initiative. European oncologists back biosimilars with position paper [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2017 Oct 27]. Available from: www.gabionline.net/Biosimilars/General/European-oncologists-back-biosimilars-with-position-paper
6. Declerck P, Giuliani R. Are biosimilars bio–the same? The biotechnology and clinical perspectives. ESMO Perspectives. 2017;3:

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