Regarding extrapolation* of indications for biosimilars, the European Medicines Agency (EMA) has stated that ‘if clinical similarity can be shown in a key indication, extrapolation of efficacy and safety data to other indication(s) of the reference product may be possible’ under certain conditions [1].
Despite this very clear statement from European Medicines Agency’s (EMA), however, concerns are often raised in the medical community about the use of biosimilars in such ‘extrapolated indications’. In fact, many medical societies, including the American College of Rheumatology, the Association of the British Pharmaceutical Industry, the European Cancer Organisation, the Mexican College of Rheumatology, and the Spanish Society of Gastroenterology [2, 3] have specifically recommended against use of biosimilars in extrapolated indications.
Such distrust in biosimilars is believed could be a cause of the lower than expected uptake for biosimilars in Europe, which is especially the case in extrapolated indications. In an attempt to address the concerns about extrapolation for biosimilars, members of European Medicines Agency's (EMA) Biosimilar Medicinal Products Working Party (BMWP) have published a manuscript titled ‘Biosimilars: the science of extrapolation’. In the manuscript the authors try to inform clinicians about the scientific concept underlying the development and licensing of biosimilars [4].
The series of six articles that follow discuss the ‘similar but not identical paradigm’, when extrapolation can be considered, and give examples of cases of the extrapolation of indications for biosimilars in Europe.
*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another medical condition.
Disclaimer
The authors of the research paper [4] declared that they are members or experts of the BMWP. This paper [4] represents solely the views of the authors and should not be understood or quoted as being made on behalf of or reflecting the position of EMA or its committees.
Conflict of interest
The authors of the research paper [4] declared that there were no conflicts of interest.
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References
1. GaBI Online - Generics and Biosimilars Initiative. Efficacy, extrapolation and interchangeability of biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Biosimilars/Research/Efficacy-extrapolation-and-interchangeability-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of biosimilar infliximab indications to inflammatory bowel disease [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-biosimilar-infliximab-indications-to-inflammatory-bowel-disease
3. GaBI Online - Generics and Biosimilars Initiative. ABPI issues updated position paper on biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Oct 24]. Available from: www.gabionline.net/Biosimilars/General/ABPI-issues-updated-position-paper-on-biosimilars
4. Weise M, Kurki P, Wolff-Holz E, Bielsky MC, Schneider CK. Biosimilars: the science of extrapolation. Blood. 2014 Oct 8. pii: blood-2014-06-583617. [Epub ahead of print]
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