SERMO asked 3,849 doctors from 28 countries whether they felt that biosimilars would prove to be safe and effective enough to prescribe them when more become available.

The results showed that half of those surveyed (53%) would not be willing to prescribe biosimilars, with 43% saying that they needed more educational information on biosimilars before they would be willing to prescribe biosimilars. On the other hand, the remaining 47% of doctors said they believed biosimilars would prove safe and effective enough to prescribe.

A common theme expressed by the doctors surveyed was the need for more testing of biosimilars. A Spanish oncologist said ‘The important thing is that they are backed by powerful studies’ and a Canadian general practitioner concluded ‘More studies and long-term follow up are warranted before concluding safety’.

An issue expressed by doctors from Latin America was their lack of confidence in the efficacy of ‘similar biotherapeutic products’. According to a Mexican dermatologist they are ‘ineffective’ and ‘caused adverse effects’. While a Venezuelan paediatrician stated that ‘their performance is 50% of the original’. It should be pointed out, however, that products approved in Latin America should not be termed ‘biosimilars’ as they have not been approved following the same strict regulatory standards required in the European Union and the US.

Another issue raised was extrapolation*. An Irish rheumatologist commented, ‘Where I have a major concern is the extrapolation of indications. This is incorrect and has only come about due to health budget issues’. 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]. The agency believes that physicians may not be well-informed about the scientific concept underlying the principle of extrapolating indications for biosimilars. It has therefore also released data on how the ‘totality of evidence’ and/or post-marketing studies indicated similar efficacy and safety of infliximab [2], filgrastim [3] and epoetin [4] compared to their reference products.

The SERMO poll was carried out by email to a random selection of members of the SERMO community in 28 countries. Participation was voluntary and results were kept anonymous. The 28 countries polled included Argentina, Australia, Austria, Canada, Chile, Columbia, Denmark, Finland, France, Germany, Great Britain, Greece, Hungary, Ireland, Israel, Italy, Mexico, The Netherlands, New Zealand, Norway, Peru, Poland, South Africa, Spain, Sweden, Switzerland, USA and Venezuela.

The SERMO survey clearly highlights the need for further education of doctors about biosimilars.

*Extrapolation involves extending and applying the data from clinical studies regarding one medical condition to another.

Editor’s comment
It should be noted that ‘similar biotherapeutic products’ approved in country might not have been authorized following as strict a regulatory process as is required for approval of biosimilars in the European Union. The EMA (European Medicines Agency) regulatory requirements ensure the same high standards of quality, safety and efficacy for biosimilars as for originator biologicals, and also include a rigorous comparability exercise with the reference product.

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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 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/Research/Efficacy-extrapolation-and-interchangeability-of-biosimilars
2. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of indications in biosimilars: infliximab [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-infliximab
3. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of indications in biosimilars: filgrastim [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-filgrastim
4. GaBI Online - Generics and Biosimilars Initiative. Extrapolation of indications in biosimilars: epoetin [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Jun 24]. Available from: www.gabionline.net/Biosimilars/Research/Extrapolation-of-indications-in-biosimilars-epoetin

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