Extrapolation may be the most contentious issue of biosimilar development, but it is also its single greatest benefit, says Dr Martina Weise of the Federal Institute for Drugs and Medical Devices in Germany.
Extrapolation of data is an established scientific and regulatory principle that has been exercised for many years when controlling any changes to how originator biologicals are manufactured, says Dr Weise, who was speaking at a roundtable on biosimilars organized by GaBI in Brussels, Belgium, earlier in 2016 [1]. If any changes are made to the way that an originator biological is manufactured, additional clinical data are not required.
Dr Weise says she and her regulatory colleagues, who have researched this issue extensively, are not aware of any case of a change in the manufacturing process where more than one clinical study was required to compare two versions of the same biological. Importantly, this system has been proven suitable for all indications of the medicine. If there is ever any doubt, she adds, additional functional or clinical data are required for extrapolation to be granted.
Dr Weise notes that the scientific evidence and an explanation of the reasons for extrapolation granted by the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) can be found in the European Public Assessment Reports (EPAR).
In line with this, Dr Elena Wolff-Holz of Germany’s Federal Agency for Vaccines and Biomedicines, and a member of EMA’s Biosimilar Medicinal Products Working Party (BMWP), has looked at a series of small to medium-sized switching studies involving biologicals and biosimilars, and found no evidence of safety/efficacy signals that would justify extensive longer studies.
A Swedish study that investigated switching between the originator and biosimilar of the growth hormone somatropin, for example, showed no impact on patients’ growth velocity after switching to the biosimilar. When a model was used to compare observed versus predicted growth, the predicted levels lay close to the observed data, showing excellent fit. Similar findings were shown for biosimilars containing epoetin alfa, biosimilar filgrastim, biosimilar insulin glargine, and biosimilar infliximab.
Representatives of medical societies attending the biosimilars roundtable in Brussels concluded that, while EMA has carried out important work looking at extrapolation and investigating the safety of biosimilars, their findings have not been communicated effectively. It was hoped that with improved communication, and a better understanding of how biological medicines are manufactured, any reluctance to prescribe biosimilars could be overcome.
Editor’s comment
This article for GaBI Online is a series of two articles prepared from the full manuscript published in GaBI Journal.
If you would like to receive a copy* of the GaBI Journal manuscript [1], please send us an email.
Readers interested to learn more about biosimilars for prescribers are invited to visit www.gabi-journal.net to view the following manuscript published in GaBI Journal:
Prescribing practices for biosimilars: questionnaire survey findings from physicians in Argentina, Brazil, Colombia and Mexico
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Reference
1. Annese V, Avendaño-Solá C, Breedveld F, Ekman N, Giezen TJ, Gomollón F, et al. Roundtable on biosimilars with European regulators and medical societies, Brussels, Belgium, 12 January 2016. Generics and Biosimilars Initiative Journal (GaBI Journal). 2016;5(2):74-83. doi:10.5639/gabij.2016.0502.019
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